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Sleepware 3.8

by Respironics Inc. 3 variants

Sleepware 3.8 (1121998) is a Class II device made by Respironics Inc., listed in FDA GUDID since 11 Jan 2017 (UDI-DI 00606959038943), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00606959038943 UDI-DI Date11 Jan 2017ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Sleepware
Generic name
Polysomnography analyser
Model / Ref / Catalog
3.8, 1121998
Primary DI / UDI-DI
00606959038943
FDA product code
OLZ
GMDN term
Polysomnography analyser
Device class
Class II
Regulation number
882.1400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Polysomnography analyser

Similar devices in this category

Other devices filed under Polysomnography analyser.

Other devices from Respironics Inc.

See all devices from Respironics Inc. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)