Who is the manufacturer of Nelson Sentinel Series Basic Chlorine Sentinel?

Nelson Environmental Technologies, Inc. filed the 510(k) submission for Nelson Sentinel Series Basic Chlorine Sentinel (K193169).

What is the FDA product code for Nelson Sentinel Series Basic Chlorine Sentinel?

MSY. It is classified under 21 CFR 876.5665 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for Nelson Sentinel Series Basic Chlorine Sentinel?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Nelson Sentinel Series Basic Chlorine Sentinel?

Ultra Low Total Chlorine and E-Z Chek Sensitive Total Chlorine Test Strips (K090338).

Who can help prepare an FDA 510(k) submission like Nelson Sentinel Series Basic Chlorine Sentinel?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Nelson Sentinel Series Basic Chlorine Sentinel

K193169 · Nelson Environmental Technologies, Inc. · MSY · Oct 29, 2020 · Gastroenterology, Urology

Device Facts

Record ID	K193169
Device Name	Nelson Sentinel Series Basic Chlorine Sentinel
Applicant	Nelson Environmental Technologies, Inc.
Product Code	MSY · Gastroenterology, Urology
Decision Date	Oct 29, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5665
Device Class	Class 2

Indications for Use

The Nelson Sentinel Series Basic Chlorine Sentinel is an instrument that is intended for use by hemodialysis professionals as an auxiliary device to provide continuous monitoring of Total chloramines plus ammoniated free chlorine) concentration. It is not intended to replace the primary method for monitoring total chlorine as part of the hemodialysis water treatment system. It functions completely independent of the water treatment system and does not come into direct contact with feed water used to prepare dialysate.

Device Story

The Nelson Sentinel Series Basic Chlorine Sentinel is an auxiliary monitoring system for hemodialysis water treatment. It uses a polarographic sensor with a polymeric membrane to detect dissolved total chlorine (chloramines and ammoniated free chlorine) in water samples taken downstream of the secondary carbon filter. The system includes a master control enclosure, a probe/tester enclosure, and a remote module for the nurse's station. It operates via a microcontroller that triggers visual (red/yellow/green LEDs) and audible alarms when chlorine concentrations exceed a 0.10 mg/L set-point or if system faults (e.g., probe failure, power loss, flood detection) occur. The device uses a peristaltic pump for automated sample delivery. It provides continuous monitoring to alert clinicians to potential chlorine breakthrough, allowing for timely intervention to prevent patient exposure to contaminated water. It does not record chlorine values but provides binary status outputs for alarm conditions.

Clinical Evidence

Bench testing only. No clinical data. Performance verified via linearity, precision, limit of blank/quantitation/detection, method comparison, peristaltic pump/tubing validation, free chlorine study, and 15-week calibration study.

Technological Characteristics

Polarographic sensor with polymeric membrane; peristaltic pump for sample delivery; PVC, stainless steel, and ABS plastic construction; 110-240 VAC power; backlit LCD display; continuous monitoring; non-networked; microcontroller-based; IEC 61010-1 and IEC 61326-1 compliant.

Indications for Use

Indicated for hemodialysis professionals to provide continuous monitoring of total chlorine (total chloramines plus ammoniated free chlorine) concentration in water treatment systems. Not for use as a primary monitoring method; does not contact feed water used for dialysate preparation.

Regulatory Classification

Identification

A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.

Special Controls

*Classification.* Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

Ultra Low Total Chlorine and E-Z Chek Sensitive Total Chlorine Test Strips (K090338)

Reference Devices

Hach CM130 Chlorine Monitor (K162471)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below. The logo is simple and professional, reflecting the FDA's role in regulating food and drugs. October 29, 2020 Nelson Environmental Technologies, Inc. QuocHuy (Huy) Nguyen New Product Development Manager/Finance Manager 813 E. Fir Avenue McAllen, TX 78501 Re: K193169 Trade/Device Name: Nelson Sentinel Series Basic Chlorine Sentinel Regulation Number: 21 CFR§ 876.5665 Regulation Name: Water Purification System for Hemodialysis Regulatory Class: II Product Code: PSX, MSY, FIP Dated: September 28, 2020 Received: September 29, 2020 Dear QuocHuy (Huy) Nguyen: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Carolyn Y. Neuland, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K193169 Device Name Nelson Sentinel Series Basic Chlorine Sentinel #### Indications for Use (Describe) The Nelson Sentinel Series Basic Chlorine Sentinel is an instrument that is intended for use by hemodialysis professionals as an auxiliary device to provide continuous monitoring of Total chloramines plus ammoniated free chlorine) concentration. It is not intended to replace the primary method for monitoring total chlorine as part of the hemodialysis water treatment system. It functions completely independent of the water treatment system and does not come into direct contact with feed water used to prepare dialysate. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ K193169 Page 6.1-1 of 6.1-20 ## 6. 510(k) Summary #### Nelson Environmental Technologies, Inc. This 510(k) Summary is in conformance with 21CFR 807.92 | Submitter: | Nelson Environmental Technologies, Inc 813 E. Fir Avenue McAllen, TX 78501 Phone: 956-618-0375 | |------------------|---------------------------------------------------------------------------------------------------------| | Primary Contact: | QuocHuy (Huy) Nguyen Email: admin@nws.bz Phone: 956-618-0375 | - Date Prepared: August 13, 2020 Device Name and Classification | Trade Name/Device Name: | Nelson Sentinel Series Basic Chlorine Sentinel | |-------------------------|------------------------------------------------| | Regulation Number: | 21 CFR 876.5665 | | Regulation Name: | Water Purification System for Hemodialysis | | Regulatory Class: | Class II | | Classification Panel: | Gastroenterology/Urology | | Product Code: | PSX, MSY, FIP | Fax: 956-618-4330 Predicate Device: | Trade Name | Ultra Low Total Chlorine (K100-0118) and E-Z Chek Sensitive Total Chlorine (K100-0106) Test Strips | |---------------------------|----------------------------------------------------------------------------------------------------| | Common Name | Total Chlorine Test Strips | | 510(k) Submitter / Holder | Reprocessing Products Corporation (RPC) | | 510(k) Number | K090338 | | Regulation Number | 21 CFR§ 876.5665 Water purification system for hemodialysis | | Classification Panel | Gastroenterology/Urology | | Product Code | MSY | {4}------------------------------------------------ #### Reference Device: | Trade Name | | Hach CM130 Chlorine Monitor | |---------------------------|--|----------------------------------------------------------------| | Common Name | | | | 510(k) Submitter / Holder | | HACH Company | | 510(k) Number | | K162471 | | Regulation Number | | 21 CFR§ 876.5665 Water Purification System For Hemodialysis | | Classification Panel | | Gastroenterology/Urology | | Product Code | | Primary Product Code PSX Secondary Product Code FIP | ### Device Description The Nelson Sentinel Series Basic Chlorine Sentinel is a complete system that attaches to the drain of a hemodialysis water treatment system sample port. The Basic Chlorine Sentinel detects dissolved chlorine by an auxiliary meter detection technology, self-monitors for maintenance-required conditions, loss of electrical power, as well as two other system conditions such as flooding and the status of RO shutdown alarm. The device chlorine monitoring probe is preferably placed after the second carbon filter, before the RO machine or at the beginning of the patient water treatment loop. The device has three components - a lockable master control enclosure, a lockable probe/tester enclosure, and the remote module installed in the patient area. A chlorine concentration equal to or above the set-point (default: 0.10mg/L) will activate the buzzers and the red CHLORINE alarm indicators for as long as the condition exists. The buzzers can only be muted for 3 minutes (then automatically reset) for as long as the condition exists. The yellow AUTO-TEST OK/CL DETECTED indication will latch. The AUTO-TEST/CL DETECTED indication can be deactivated after the event by pressing the blue RESET PUSHBUTTON on the front cover of the controller. A probe failure or the activation of one of the auxiliary input relays will activate the yellow MAINTENANCE needed indicators as well as the Buzzers which will remain activated as long as the condition exists. However, the buzzers can be muted by the key mute switch while the maintenance issue is being resolved. #### Indications for Use The Nelson Sentinel Series Basic Chlorine Sentinel is an instrument that is intended for use by hemodialysis professionals as an auxiliary device to provide continuous monitoring of Total Chlorine. (i.e. total chloramines plus ammoniated free chlorine) concentration. It is not intended to replace the primary method for monitoring total chlorine as part of the hemodialysis water {5}------------------------------------------------ treatment system. It functions completely independent of the water treatment system and does not come into direct contact with feed water used to prepare dialysate. #### Risk Analysis Method Nelson Sentinel Series Basic Chlorine Sentinel was assessed to determine risks to health associated with the use of the device, a risk analysis was conducted in accordance with ISO 14971: 2007, Medical devices - Application of risk management to medical devices. #### Substantial Equivalence The table below provides a detailed comparison of Nelson Sentinel Series Basic Chlorine Sentinel to the predicate and reference devices. {6}------------------------------------------------ ## Detailed Comparison of the Subject and Predicate Devices | ltem | Subject Device Nelson Sentinel Series Basic Chlorine Sentinel | Predicate Device UltraLow Total Chlorine and E-Z Chek Sensitive Total Chlorine Test Strips | Reference Device Hach CM130 Chlorine Monitor | Comparison | |-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use/Indications for Use | The Nelson Sentinel Series Basic Chlorine Sentinel is an instrument that is intended for use by hemodialysis professionals as an auxiliary device to provide continuous monitoring of Total Chlorine. (i.e. total chloramines plus ammoniated free chlorine) concentration. It is not intended to replace the primary method for monitoring total chlorine as part of the hemodialysis water treatment system. It functions completely independent of the water treatment system and does not come into direct contact with feed water used to prepare dialysate. | The Reprocessing Product Corporation (RPC) Total Chlorine Test Strips are indicated for detection of Free Chlorine and Total Chlorine in water. These Test Strips are indicated for testing water used to prepare dialysate (Free Chlorine and Chloramines) and for testing rinse water following dialysis equipment disinfection (Free Chlorine). | N/A; Nelson Sentinel Series Basic Chlorine Sentinel is compared to UltraLow Total Chlorine and E-Z Chk Sensitive Total Chlorine Test Strips for Intended Use and Indications For Use. | The Nelson Sentinel Series Basic Chlorine Sentinel intended use / indications for use is identical to the UltraLow Total Chlorine and E-Z Chek Sensitive Total Chlorine Test Strips intended use and indications for use, related to the detection of Total Chlorine in Water and testing water used to prepare dialysate. | | Item | Subject Device Nelson Sentinel Series Basic Chlorine Sentinel | Predicate Device UltraLow Total Chlorine and E-Z Chek Sensitive Total Chlorine Test Strips | Reference Device Hach CM130 Chlorine Monitor | Comparison | | Provides Exact Chlorine Value? | No; Intended to indicate chlorine above set-point only | No; Indicates an approximate, semi- quantitative value based on the colorimetric method, which can be used to confirm if chlorine is above a specific value | Yes; presents an exact chlorine value on its display intended to be used to make clinical decisions | Nelson Sentinel Series Basic Chlorine Sentinel is equivalent to UltraLow Total Chlorine and E-Z Chek Sensitive Total Chlorine Test Strips. | | Detection Chemistry/ Technology | Direct measuring polarographic sensor utilizing a special polymeric membrane. | N/A | DPD Colorimetric Method | Nelson Sentinel Series Basic Chlorine Sentinel uses a different detection technology from Hach CM130 Chlorine Monitor. The difference in detection technology does not affect the intended use or the safety of the device. | | Chlorine Sensor Type | Polarographic sensor | N/A | Photometric sensor | Nelson Sentinel Series Basic Chlorine Sentinel uses a different sensor from Hach CM130 Chlorine Monitor. The difference in sensor type does not affect the intended use or the safety of the device. | | ltem | Subject Device Nelson Sentinel Series Basic Chlorine Sentinel | Predicate Device UltraLow Total Chlorine and E-Z Chek Sensitive Total Chlorine Test Strips | Reference Device Hach CM130 Chlorine Monitor | Comparison | | Reagents | Ammonium sulfate | N/A | Indicator solution (DPD indicator with potassium iodide), buffer solution | The reagents used by Nelson Sentinel Series Basic Chlorine Sentinel and Hach CM130 Chlorine Monitor are different. The difference in reagents used does not affect the intended use or safety and effectiveness of the device. | | Reagent Delivery | Peristaltic pump | N/A | Peristaltic pump | Nelson Sentinel Series Basic Chlorine Sentinel is identical to Hach CM130 Chlorine Monitor. | | Type of Chlorine Detected | Total Chlorine (free chlorine plus total chloramines) | N/A | Total Chlorine (free chlorine plus total chloramines) | Nelson Sentinel Series Basic Chlorine Sentinel is identical to Hach CM130 Chlorine Monitor. | | ltem | Subject Device Nelson Sentinel Series Basic Chlorine Sentinel | Predicate Device UltraLow Total Chlorine and E-Z Chek Sensitive Total Chlorine Test Strips | Reference Device Hach CM130 Chlorine Monitor | Comparison | | Detection Range | 0.05 mg/L Cl2- 0.15 mg/L Cl2 | N/A | 0.03 mg/L Cl2- 0.20 mg/L Cl2 | Nelson Sentinel Series Basic Chlorine Sentinel is able to detect a wider range of chlorine levels than Hach CM130 Chlorine Monitor. This difference in detection range does not affect the intended use or safety and effectiveness of the device. | | Allowable Chlorine Level | 0.1 mg/L Cl2 | N/A | 0.1 mg/L Cl2 | Nelson Sentinel Series Basic Chlorine Sentinel is identical to Hach CM130 Chlorine Monitor. | | Sampling | The chlorine sensor is located on the downstream side of a water treatment test sample port. The sampled water is then discharged down the drain. | N/A | Feed water is sampled. Water that flows into the CM130 device exits the device to a drain. The water samples, once tested, are also discarded to a drain. | Nelson Sentinel Series Basic Chlorine Sentinel is equivalent to Hach CM130 Chlorine Monitor. | | Water Sample Conditioning and Delivery | Automated | N/A | Automated | Nelson Sentinel Series Basic Chlorine Sentinel is identical to Hach CM130 Chlorine Monitor. | | ltem | Subject Device Nelson Sentinel Series Basic Chlorine Sentinel | Predicate Device UltraLow Total Chlorine and E-Z Chek Sensitive Total Chlorine Test Strips | Reference Device Hach CM130 Chlorine Monitor | Comparison | | Measurement Interval | Continuous | N/A | 5 minutes | Nelson Sentinel Series Basic Chlorine Sentinel has a higher measurement interval than Hach CM130 Chlorine Monitor. This difference in measurement interval does not affect the safety or effectiveness of the device. | | Alarms/ Alerts | Controller: Three colors (green for power indication, and yellow and red for alerts) and a buzzer Remote Module: Three colors (green for power indication, yellow and red for alerts) and a buzzer | N/A | Analyzer: Two colors (amber and red) on the display and three sounds for notifications. Remote Indicator: Two lights show the analyzer status (blue, amber, or red). Two lights show the chlorine status (blue, amber, or red). Three different sounds: hardware alarm, medium-high chlorine alert, and high chlorine alarm. | Nelson Sentinel Series Basic Chlorine Sentinel is equivalent to Hach CM130 Chlorine Monitor. Differences in light colors and types of sounds do not affect the intended use or safety and effectiveness of the device. | | ltem | Subject Device Nelson Sentinel Series Basic Chlorine Sentinel | Predicate Device UltraLow Total Chlorine and E-Z Chek Sensitive Total Chlorine Test Strips | Reference Device Hach CM130 Chlorine Monitor | Comparison | | Measurement Point | After the secondary carbon filter, before the reverse osmosis (RO) machine. | N/A | Between the primary and secondary carbon tanks (filters). | Nelson Sentinel Series Basic Chlorine Sentinel is different from Hach CM130 Chlorine Monitor. This difference in measurement point does not affect the intended use or the safety and effectiveness of the device. | | Device Location | Remote Module is located in the nurse's station: all other components are located in the water room | N/A | Remote indicator is located in the patient room; all other components are located in the water room | Nelson Sentinel Series Basic Chlorine Sentinel is equivalent to Hach CM130 Chlorine Monitor. | | Remote Indicator | Yes | N/A | Yes | Nelson Sentinel Series Basic Chlorine Sentinel is identical to Hach CM130 Chlorine Monitor. | | Enclosure to protect electronics from splashing or spills | Yes | N/A | Yes | Nelson Sentinel Series Basic Chlorine Sentinel is identical to Hach CM130 Chlorine Monitor. | | Item | Subject Device Nelson Sentinel Series Basic Chlorine Sentinel | Predicate Device UltraLow Total Chlorine and E-Z Chek Sensitive Total Chlorine Test Strips | Reference Device Hach CM130 Chlorine Monitor | Comparison | | Water Treatment? | No | N/A | No | Nelson Sentinel Series Basic Chlorine Sentinel is identical to Hach CM130 Chlorine Monitor. | | Device Components | Controller, Probe/Tester, Remote Module | N/A | Analyzer, Remote Indicator | Nelson Sentinel Series Basic Chlorine Sentinel is equivalent to Hach CM130 Chlorine Monitor. This difference in device components does not affect the intended use or safety and effectiveness of the device. | | Control Mechanism | Microcontroller | N/A | Microcontroller | Nelson Sentinel Series Basic Chlorine Sentinel is identical to Hach CM130 Chlorine Monitor. | | Maintenance | Quarterly | N/A | Monthly | Nelson Sentinel Series Basic Chlorine Sentinel requires less frequent maintenance than Hach CM 130 Chlorine Monitor. The difference in maintenance interval does not affect the intended use or safety and effectiveness of the device. | | ltem | Subject Device Nelson Sentinel Series Basic Chlorine Sentinel | Predicate Device UltraLow Total Chlorine and E-Z Chek Sensitive Total Chlorine Test Strips | Reference Device Hach CM130 Chlorine Monitor | Comparison | | Data Logger | No data logger. | N/A | 3000 measurements maximum | Data logging features are not available for Nelson Sentinel Series Basic Chlorine Sentinel. This difference does not affect the intended use or safety and effectiveness of the device. | | Status Outputs | Five water treatment status outputs: (1) Continuous auxiliary monitoring of Total Chlorine (i.e. total chloramines plus ammoniated free chlorine) concentration (this is not to be confused with primary or secondary testing for chlorine. The device display is for calibration function only and is not to be used for accurate chlorine concentration readings. The device | N/A | High chlorine | Nelson Sentinel Series Basic Chlorine Sentinel provides additional status outputs from the Hach CM130 Chlorine Monitor. This difference does not affect the intended use or safety and effectiveness of the device. | | Item | Subject Device Nelson Sentinel Series Basic Chlorine Sentinel | Predicate Device UltraLow Total Chlorine and E-Z Chek Sensitive Total Chlorine Test Strips | Reference Device Hach CM130 Chlorine Monitor | Comparison | | | does not record usable chlorine concentration values, it only compares the actual concentration to the set-point). When the concentration equals or exceeds the pre-set set-point, the notification output is activated. Notification closes Output Relay #1; (2) Loss of system or facility mains electrical power. Default Output Relay #2; (3) Aux#1 Input (recommended for the status of flood detection monitors), (it does not control any equipment). Notification closes Output Relay #3; (4) Aux #2 Input (recommended for the | | | | | Item | Subject Device Nelson Sentinel Series Basic Chlorine Sentinel | Predicate Device UltraLow Total Chlorine and E-Z Chek Sensitive Total Chlorine Test Strips | Reference Device Hach CM130 Chlorine Monitor | Comparison | | | status of flood detection monitors), (it does not control any equipment) Notification closes Output Relay #4 (5) Self-diagnostic system failures or maintenance required. | | | | | Display | Backlit LCD: 1.91 cm (0.75 in.)high 4-digit main display, 0.76 cm (0.3 in.) 5x7 dot matrix 12-digit secondary display | N/A | 10.9 cm (4.3 in.) color display, backlit LCD WQVGA | Nelson Sentinel Series Basic Chlorine Sentinel is equivalent to Hach CM130 Chlorine Monitor, with the only difference being that Nelson Sentinel Series Basic Chlorine has a smaller screen than Hach CM130 Chlorine Monitor. This difference in screen size does not affect safety or effectiveness of the device. | | Power Requirement…

Nelson Sentinel Series Basic Chlorine Sentinel

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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Nelson Sentinel Series Basic Chlorine Sentinel

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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