PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P

Q: Who is the manufacturer of PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P?

Comdek Industrial Corp. filed the 510(k) submission for PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P (K083351).

Q: What is the FDA product code for PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P?

DQA. It is classified under 21 CFR 870.2700 as a Class 2 device in the Cardiovascular panel.

Q: What is the regulatory pathway for PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P?

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

Q: Who can help prepare an FDA 510(k) submission like PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P?

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.

K083351 · Comdek Industrial Corp. · DQA · Apr 24, 2009 · Cardiovascular

Device Facts

Record ID	K083351
Device Name	PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P
Applicant	Comdek Industrial Corp.
Product Code	DQA · Cardiovascular
Decision Date	Apr 24, 2009
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2700
Device Class	Class 2

Intended Use

The COMDEK Portable Pulse Oximeter MD-600P offers non-invasive continuous and instantaneous monitoring, and provides users with high-level accuracy and a quick measuring response. The environments for use are hospitals, intra-hospital transport, hospital-type facilities and the home. The device is intended for use only with adults.

Device Story

Portable pulse oximeter; provides non-invasive, continuous, instantaneous monitoring of oxygen saturation and pulse rate. Inputs: optical signals via finger sensor. Processing: signal filtering and calculation of SpO2 and pulse rate. Outputs: digital display of SpO2 and pulse rate. Used in hospitals, during transport, and home settings; operated by clinicians or patients. Output used for patient status assessment; facilitates clinical decision-making regarding oxygenation status.

Clinical Evidence

Bench testing only.

Technological Characteristics

Non-invasive pulse oximetry; spectrophotometric sensing principle; portable form factor; battery-powered; digital display; intended for adult use.

Indications for Use

Indicated for non-invasive continuous and instantaneous monitoring of oxygen saturation and pulse rate in adult patients in hospitals, intra-hospital transport, hospital-type facilities, and home settings.

Regulatory Classification

Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Related Devices

K141542 — NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS ) · Covidien, LLC · Oct 2, 2014
K024235 — DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER · Dolphin Medical, Inc. · Mar 17, 2003
K051352 — OXIMAX NPB-40 HANDHELD PULSE OXIMETER · Nellcor Puritan Bennett, Inc. · Aug 11, 2005
K021959 — DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100 · Dolphin Medical, Inc. · Jul 11, 2002
K103285 — DIXTAL DZ-4100 SERIES PULSE OXIMETER · Dixtal Medical, Inc. · Jul 25, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized symbol resembling three overlapping human figures or abstract shapes, rendered in a bold, black color. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## APR 2 4 2009 Y.S. Kuo General Manager Comdek Industrial Corporation 9F-1, No. 3 Yuan Qu Street, Nan Kang Taipei CHINA 11503 Re: K083351 Trade/Device Name: Comdek Portable Pulse Oximeter MD-600P Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: October 30, 2008 Received: January 29, 2009 Dear Y.S. Kuo: 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. 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. 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 statutes and regulations administered by other Federal agencies. {1}------------------------------------------------ Page 2- Y.S. Kuo 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. > Sincerely yours. Whan uno en Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number: K083351 ### Device Name: COMDEK PORTABLE PULSE OXIMETER MD-600P Indications for Use: The COMDEK Portable Pulse Oximeter MD-600P offers non-invasive continuous and instantaneous monitoring, and provides users with high-level accuracy and a quick measuring response. The environments for use are hospitals, intra-hospital transport, hospital-type facilities and the home. The device is intended for use only with adults. Prescription Use XXX (Part 21 CFR 801 Subpart D) Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) (Division Sign-Off) (Division Sign-Off) Division of Anestheshology MERRESS (Device Evaluation (ODE) Infection Control, Dental Devices 510(k) Number: