510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K092003Substantially Equivalent

Cpc Sleep Data Recorder, Model M1, and Application Software

Mycardio, Broomfield CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092003 is the FDA 510(k) clearance record for CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE, a class II device, cleared for MyCardio, LLC on under FDA product code MNR (Ventilatory Effort Recorder). FDA records list one 510(k) clearance for MyCardio, LLC. As of , FDA records show no recalls naming K092003.

Clearance record

Decision date
Received
(90 days to decision)
Product code
MNR Ventilatory Effort Recorder
Regulation
21 CFR 868.2375
Device class
Class II
Review panel
Anesthesiology
Applicant
MyCardio, LLC 11001 W. 120th Ave., Broomfield CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MNR

Trailing 12 months
6 clearances under product code MNR in the twelve months to October 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MNR, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20261
July 20262
August 20260
September 20261
October 20260