510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993618Substantially Equivalent

Dxp1000 Holter Recorder

Braemar Manufacturing, LLC, Burnsville MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K993618 is the FDA 510(k) clearance record for DXP1000 HOLTER RECORDER, a class II device, cleared for Braemar Corp. on under FDA product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)). FDA records list 13 510(k) clearances for BRAEMAR MANUFACTURING, LLC, from to . As of , FDA records show no recalls naming K993618.

Clearance record

Decision date
Received
(29 days to decision)
Product code
MWJ Electrocardiograph, Ambulatory (Without Analysis)
Regulation
21 CFR 870.2800
Device class
Class II
Review panel
Cardiovascular
Applicant
Braemar Corp. 11481 Rupp Dr., Burnsville MN
510(k) summary
Summary
Third party review
No

Clearances, product code MWJ

Trailing 12 months
5 clearances under product code MWJ in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MWJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20260
August 20261
September 20262
October 20260