510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K963597Substantially Equivalent

Silent Night I

Local Silence, Inc., Los Altos CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963597 is the FDA 510(k) clearance record for SILENT NIGHT I, a class II device, cleared for Local Silence, Inc. on under FDA product code MNR (Ventilatory Effort Recorder). FDA records list one 510(k) clearance for Local Silence, Inc. As of , FDA records show no recalls naming K963597.

Clearance record

Decision date
Received
(136 days to decision)
Product code
MNR Ventilatory Effort Recorder
Regulation
21 CFR 868.2375
Device class
Class II
Review panel
Anesthesiology
Applicant
Local Silence, Inc. 935 Fremont Ave., Suite 115, Los Altos CA
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