510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K003499Substantially Equivalent

Remview Sleep Recorder, Model 320

Respironics, Inc., Murrysville PA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K003499 is the FDA 510(k) clearance record for REMVIEW SLEEP RECORDER, MODEL 320, a class II device, cleared for Respironics, Inc. on under FDA product code LEL (Device, Sleep Assessment). FDA records list 186 510(k) clearances for Respironics, Inc., from to . As of , FDA records show no recalls naming K003499.

Clearance record

Decision date
Received
(88 days to decision)
Product code
LEL Device, Sleep Assessment
Regulation
21 CFR 882.5050
Device class
Class II
Review panel
Neurology
Applicant
Respironics, Inc. 1001 Murry Ridge Ln., Murrysville PA
510(k) summary
Summary
Third party review
No

Clearances, product code LEL

Trailing 12 months
1 clearance under product code LEL in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LEL, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260