ClearanceBrief
Company ยท US

Braemar Manufacturing, LLC

FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2018. Name variants (Inc, Corp, punctuation) are merged.

3510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
2recalls that name a 510(k)

Product codes

CodeDeviceRecords
MWJElectrocardiograph, Ambulatory (Without Analysis)3
DPSElectrocardiograph1
DSHRecorder, Magnetic Tape, Medical1
DSIDetector And Alarm, Arrhythmia1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jan 4, 2018K171410ePatch
Braemar Manufacturing, LLC
DSH
Jul 22, 2016K153473Braemar Telemetry Patch System
Braemar Manufacturing, LLC
DSI
Oct 16, 2013K130294BRAEMAR CARDIOKEY HOLTER RECORDER
Braemar Manufacturing, LLC
MWJ

Latest recalls

DateFirm and productCodeLinked 510(k)
Dec 23, 2024Braemar Manufacturing, LLC
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
Open, Classified		 DPSNone listed
Jan 22, 2020Braemar Manufacturing, LLC
Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
Terminated		 MWJK071733
Jan 22, 2020Braemar Manufacturing, LLC
Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
Terminated		 MWJK071733
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