510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K981034Substantially Equivalent

Silent Night II

Sleep Solutions, Inc., Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981034 is the FDA 510(k) clearance record for SILENT NIGHT II, a class II device, cleared for Sleep Solutions, Inc. on under FDA product code MNR (Ventilatory Effort Recorder). FDA records list 2 510(k) clearances for Sleep Solutions, Inc., from to . As of , FDA records show no recalls naming K981034.

Clearance record

Decision date
Received
(225 days to decision)
Product code
MNR Ventilatory Effort Recorder
Regulation
21 CFR 868.2375
Device class
Class II
Review panel
Anesthesiology
Applicant
Sleep Solutions, Inc. 9223 Ilona Ln., Houston TX
510(k) summary
Summary
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