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AccuSom 1017-50003-US

by Novasom, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860512000291 UDI-DI Date13 Jan 2023ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
AccuSom
Generic Name
Home-use sleep apnoea recording system
Model / Reference
1017-50003-US
Primary DI / UDI-DI
00860512000291
510(k) Number
FDA Product Code
MNR
GMDN Term
Home-use sleep apnoea recording system
Device Class
Class II
Regulation Number
868.2375
GUDID distribution status
Not in Commercial Distribution

Other devices from Novasom, Inc.

  • Accusom

    Class II

Properties

  • Prescription Use
  • Convenience Kit
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No