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FORA Spiro10b

by Fora Care Inc. 2 variants

Listed FDA GUDID listing, no authorization on record

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 Number00816042015045 UDI-DI Date18 May 2026ListedStatusListed GUDID: 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  • Withdrawn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
Fora
Generic Name
Expiratory peak flow meter, digital
Model / Reference
Spiro10b
Primary DI / UDI-DI
00816042015045
510(k) Number
FDA Product Code
BZH
GMDN Term
Expiratory peak flow meter, digital
Device Class
Class II
Regulation Number
868.1860
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K222810)

Other devices from Fora Care Inc.

See all devices from Fora Care Inc. →

Properties

  • Over-the-Counter
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No