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Fitfaith M160

by Shenzhen Fitfaith Technology Co., Ltd

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 Number06970953260025 UDI-DI Date15 May 2018ListedStatusListed 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  • Withdrawn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
Fitfaith
Generic Name
Pulse oximeter
Model / Reference
M160
Primary DI / UDI-DI
06970953260025
510(k) Number
FDA Product Code
DQA
GMDN Term
Pulse oximeter
Device Class
Class II
Regulation Number
870.2700
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K163135)

Other devices from Shenzhen Fitfaith Technology Co., Ltd

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

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