(23 days)
The device is indicated for diagnostic evaluation of patients who experience transient symptoms such as; dizziness, palpitations, syncope, or chest pain. The device is intended to record cardiac activity associated with these infrequent and transient symptoms. Once data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review by a licensed physician.
Braemar ER800 Series Enhanced Algorithm Event Recorder
This document is a 510(k) clearance letter from the FDA for the Braemar ER800 Series Enhanced Algorithm Event Recorder. It does not contain information about acceptance criteria, device performance, study details, or ground truth establishment.
Therefore, I cannot provide the requested information based on the provided text. The document is an administrative clearance and does not include technical or clinical study data.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 6 - 2004
Braemar, Inc. c/o Mr. Darren Dershem Regulatory Affairs Representative 11481 Rupp Drive Burnsville, MN 55337
Re: K042469
Ko42407
Trade Name: Braemar ER800 Series Enhanced Algorithm Event Recorder Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (two) Product Code: MWJ Dated: September 08, 2004 Received: September 13, 2004
Dear Mr. Dershem:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector 310(a) pecies is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars as a reading to the Medical Device Amendments, or to commerce prior to rilly 20, 1978) as ecordance with the provisions of the Federal Food, Drug. de vices that have been require approval of a premarket approval application (PMA). and Costine rice (110.) that to nevelance subject to the general controls provisions of the Act. The 1 ou may, utcrerere, market the Act include requirements for annual registration, listing of general controlo provision 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 If your device is elassinod (tools. Existing major regulations affecting your device can may be subject to back additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Darren Dershem
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I Drivisation that your device complies with other requirements of the Act that I DA has made a actor regulations administered by other Federal agencies. You must or any I catal statutes and registments, including, but not limited to: registration and listing (21 Comply with an the Fee ore cart 801); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050. product ladiation control pro herens (evens (evice as described in your Section 510(k) I mis letter wiff anow yours ough finding of substantial equivalence of your device to a legally prematicated predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please if you desire specific acrioliance at (301) 594-4646. Also, please note the regulation entitled, Connact the Office of Court Courtemarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
B. Benima for
R.D. Zuckerman, M.D.
Bran D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Braemar ER800 Series Enhanced Algorithm Event Recorder
Indications For Use:
The device is indicated for diagnostic evaluation of patients who experience transient symptoms such as; dizziness, palpitations, syncope, or chest pain. The device is intended to record cardiac activity associated with these infrequent and transient symptoms. Once data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review by a licensed physician.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blummmor
(Division Sign 6-12
Alsion Sign-Off) Division of Cardiovascular 510(k) Number
Page 1 of
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).