BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720

K981394 · Braemar Corp. · DXH · Sep 28, 1998 · Cardiovascular

Device Facts

• Record ID: K981394
• Device Name: BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720
• Applicant: Braemar Corp.
• Product Code: DXH · Cardiovascular
• Decision Date: Sep 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Intended Use

To RECORD INFREQUENT AND ELUSIVE ECG HEART ARREHYTHMIA DATA. ONCE THE EVENT IS RECORDED PATIENTS TRANSMIT THE RECORDED ECG DATA OVER THE TELEPHONE, OR, AS AN ALTER NATE, THE ER 700 SERIES ALLOWS THE ECG DATA To BE TRANSFERRED DIRECTLY To A HOST PC IF THE PATIENT RETURNS THE UNIT To THE CLINIC.

Device Story

The Braemar ER700 Series is a patient-activated ambulatory ECG event monitor; records ECG data to capture infrequent/elusive arrhythmias. Device features looping memory; stores data in non-volatile flash memory. Patients initiate recording during symptomatic events; data transmitted via telephone or transferred directly to a host PC upon return to clinic. Device includes LCD display; operates on two AAA batteries. Used in ambulatory settings; patient-operated. Healthcare providers review ECG data on host PC to assist in arrhythmia diagnosis and clinical decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and bench testing comparisons to the predicate device.

Technological Characteristics

Ambulatory ECG event monitor; 1 or 2 channels; non-volatile flash memory; LCD display; powered by two AAA batteries; includes belt clip. Connectivity: transtelephonic transmission and direct PC data transfer. Software: embedded firmware for event recording and data management.

Indications for Use

Indicated for patients requiring recording of infrequent and elusive ECG heart arrhythmias.

Regulatory Classification

Identification

A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.

Predicate Devices

• Braemar ER300 Series (K923930)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol features a stylized human figure within a circle, while the text reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in bold, sans-serif font. The logo is black and white.

May 18, 2018

Braemar Corp. David Norberg Regulatory Affairs Representative 11481 Rupp Dr. Burnsville, Minnesota 55337

Re: K981394

Trade/Device Name: Braemar ER700 Series Ambulatory ECG Event Monitor Models ER710, ER720 Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone electrocardiograph transmitter and receiver Regulatory Class: Class II Product Code: DXH Dated: July 15, 1998 Received: July 17, 1998

Dear David Norberg:

This letter corrects our substantially equivalent letter of September 28. 1998.

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. 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 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); good

{1}------------------------------------------------

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.

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Tina Kiang
-S

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Page 1 of 1

510(k) NUMBER (IF KNOWN): K981394

DEVICE NAME: ER 700 SERIES AECG EVENT MONITOR

INDICATIONS FOR USE:

To RECORD INFREQUENT AND ELUSIVE ECG HEART ARREHYTHMIA DATA. ONCE THE EVENT IS RECORDED PATIENTS TRANSMIT THE RECORDED ECG DATA OVER THE TELEPHONE, OR, AS AN ALTER NATE, THE ER 700 SERIES ALLOWS THE ECG DATA To BE TRANSFERRED DIRECTLY To A HOST PC IF THE PATIENT RETURNS THE UNIT To THE CLINIC.

( PLEASE DO MOT WRITE BELOW THIS LINE-CONFINUE ON "ANOTHER" "PAGE" " IF NEEDED. )

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format 1-2-96

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices

510(k) Number

.. :.

{3}------------------------------------------------

K981344

## SEP 28 1998

## SECTION 2. SUMMARY & CERTIFICATION

510(k) SUMMARY

- Submitted By: Braemar, Inc. . 11481 Rupp Drive Burnsville, MN 55337
- Contact Person: David Norberg ●
- ER700 Series Cardiac Event Monitor ● Device: Class: Da
- The ER700 Series is a family of patient-activated ambulatory . Description: electrocardiograph event recorders.
- To record infrequent and elusive ECG heart arrhythmia data. Once ● Intended Use: an event is recorded, patients transmit the recorded ECG data over the telephone. Or, as an alternative, the ER700 Series allows the ECG data to be transferred directly to a host PC if the patient returns the unit to the clinic.
- Substantially Equivalent (SE) To: ●

Braemar ER300 Series 510(k) # K923930

| Attribute | ER700 Series | ER300 Series |
|---------------------------------|----------------------|------------------------|
| Liquid Crystal Display<br>(LCD) | Yes | No |
| Looping memory | Yes | Yes |
| Memory type | Flash (non-volatile) | Solid State (volatile) |
| Number of ECG channels | One or two | One or two |
| Transtelephonic data transfer | Yes | Yes |
| Belt clip | Yes | Yes |
| Direct Data Transfer | Yes | No |
| Battery | Two AAA | One 9V |

- Comparison To The SE Device: ●