510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080427Substantially Equivalent

Watch-Pat Model 100S-2

Itamar Medical, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080427 is the FDA 510(k) clearance record for WATCH-PAT MODEL 100S-2, a class II device, cleared for Itamar Medical on under FDA product code MNR (Ventilatory Effort Recorder). FDA records list 17 510(k) clearances for Itamar Medical, from to . As of , FDA records show no recalls naming K080427.

Clearance record

Decision date
Received
(98 days to decision)
Product code
MNR Ventilatory Effort Recorder
Regulation
21 CFR 868.2375
Device class
Class II
Review panel
Anesthesiology
Applicant
Itamar Medical 555 Thirteenth St. NW, Washington DC
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