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FDA 510(k)

BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720

K-Number: K981394 · 1998-09-28

ApplicantBraemar Corp.
Decision Date1998-09-28
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720 is the device name listed in this FDA 510(k) record. The listed applicant is Braemar Corp.. It received FDA 510(k) clearance on 1998-09-28 under 510(k) number K981394. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720?

BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720 is a medical device that received FDA 510(k) clearance on 1998-09-28. The listed applicant is Braemar Corp.. The 510(k) number is K981394.

When did BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720 receive FDA 510(k) clearance?

BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720 received FDA 510(k) clearance on 1998-09-28, under 510(k) number K981394.

Who is the listed applicant for BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720?

The FDA 510(k) record lists Braemar Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720?

The FDA product code for BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720 is DXH. This falls under the Hematology category.

Related Clinical Trials

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Other records listing Braemar Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K030856ER800 SERIES ECG EVENT RECORDERK993617DIGITRAKPLUS HOLTER RECORDERK993618DXP1000 HOLTER RECORDERK945130BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER

Related Devices (Code: DXH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc.K243438MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd.K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.K233521QT ECG (QTERD100)QT Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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