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Apk 700-1006-32

by APK Technology Co., Ltd.

Apk 700-1006-32 is a Class II device made by APK Technology Co., Ltd., cleared under FDA 510(k) K170536 on 24 Apr 2017 and listed in FDA GUDID since 17 Sep 2025 (UDI-DI 06946725547212), active as of 12 Nov 2026.

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 12 Nov 2026

Documents

510(k) K170536

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06946725547212 UDI-DI Date17 Sep 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170536 Date24 Apr 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170536 decided 24 Apr 2017 Active
  • FDA GUDID UDI-DI 06946725547212 listed 17 Sep 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K170536
  2. Listed FDA GUDID 06946725547212

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  • Withdrawn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
700-1006-32
Primary DI / UDI-DI
06946725547212
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

Category: Electrocardiographic lead set, single-use

Cleared under the same submission (K170536)

and 8 more cleared under K170536

Similar devices

Other devices filed under FDA product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)).

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, all answered No)