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Apk S310-97D0

by APK Technology Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 2 Nov 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06946725572818 UDI-DI Date14 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 2 Nov 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Apk
Generic Name
Pulse oximeter probe, reusable
Model / Reference
S310-97D0
Primary DI / UDI-DI
06946725572818
510(k) Number
FDA Product Code
DQA
GMDN Term
Pulse oximeter probe, reusable
Device Class
Class II
Regulation Number
870.2700
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K082846)

Show all (12)

Other devices from APK Technology Co., Ltd.

See all devices from APK Technology Co., Ltd. →

Properties

  • Serial Number
  • Manufacturing Date

Other properties (12)

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