510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K182618Substantially Equivalent

SleepImage System

Mycardio, LLC dba Sleepimage., Denver CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182618 is the FDA 510(k) clearance record for SleepImage System, a class II device, cleared for Mycardio, LLC Dba Sleepimage. on under FDA product code MNR (Ventilatory Effort Recorder). FDA records list 2 510(k) clearances for Mycardio, LLC Dba Sleepimage., from to . As of , FDA records show no recalls naming K182618.

Clearance record

Decision date
Received
(324 days to decision)
Product code
MNR Ventilatory Effort Recorder
Regulation
21 CFR 868.2375
Device class
Class II
Review panel
Anesthesiology
Applicant
Mycardio, LLC Dba Sleepimage. 3513 Brighton Blvd., Suite 530, Denver 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