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Apk Ph-989803172031

by APK Technology Co., Ltd.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 9 Nov 2026

Documents

510(k) K170536

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 9 Nov 2026. What this means

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06946725572924 UDI-DI Date26 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170536 Date24 Apr 2017DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 9 Nov 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Apk
Generic name
Electrocardiographic lead set, single-use
Model / reference
PH-989803172031
Primary DI / UDI-DI
06946725572924
510(k) Number
FDA product code
DSA
GMDN term
Electrocardiographic lead set, single-use
Device class
Class II
Regulation number
870.2900
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K170536)

Show all (12)

Other devices from APK Technology Co., Ltd.

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

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date

Other properties (10)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No