510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K210036Substantially Equivalent

Carnation Ambulatory Monitor (CAM)

Bardy Diagnostics, Inc., Seattle WA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K210036 is the FDA 510(k) clearance record for Carnation Ambulatory Monitor (CAM), a class II device, cleared for Bardy Diagnostics, Inc. on under FDA product code DSH (Recorder, Magnetic Tape, Medical). FDA records list 7 510(k) clearances for Bardy Diagnostics, Inc., from to . As of , FDA records show no recalls naming K210036.

Clearance record

Decision date
Received
(30 days to decision)
Product code
DSH Recorder, Magnetic Tape, Medical
Regulation
21 CFR 870.2800
Device class
Class II
Review panel
Cardiovascular
Applicant
Bardy Diagnostics, Inc. 316 Occidental Ave. S., Seattle WA
510(k) summary
Statement
Third party review
No

Clearances, product code DSH

Trailing 12 months
3 clearances under product code DSH in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260