510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K083620Substantially Equivalent

Somnolyzer 24X7

The Siesta Group North America, Dedham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083620 is the FDA 510(k) clearance record for SOMNOLYZER 24X7, a class II device, cleared for The Siesta Group North America on under FDA product code MNR (Ventilatory Effort Recorder). FDA records list one 510(k) clearance for The Siesta Group North America. As of , FDA records show no recalls naming K083620.

Clearance record

Decision date
Received
(88 days to decision)
Product code
MNR Ventilatory Effort Recorder
Regulation
21 CFR 868.2375
Device class
Class II
Review panel
Anesthesiology
Applicant
The Siesta Group North America 990 Washington St., Suite 204, Dedham MA
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