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Sensoronics SECG-PHP3L-1603

by Sensoronics Incorporated

Sensoronics SECG-PHP3L-1603 is a Class II device made by Sensoronics Incorporated, cleared under FDA 510(k) K120010 on 19 Jan 2012 and listed in FDA GUDID since 26 Sep 2016 (UDI-DI 00851456007569), active as of 22 Oct 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 22 Oct 2026

Documents

510(k) K120010

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00851456007569 UDI-DI Date26 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK120010 Date19 Jan 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K120010 decided 19 Jan 2012 Active
  • FDA GUDID UDI-DI 00851456007569 listed 26 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K120010
  2. Listed FDA GUDID 00851456007569

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sensoronics
Generic name
Electrocardiographic lead set, reusable
Model / reference
SECG-PHP3L-1603
Primary DI / UDI-DI
00851456007569
510(k) Number
FDA product code
DSA
GMDN term
Electrocardiographic lead set, reusable
Device class
Class II
Regulation number
870.2900
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrocardiographic lead set, reusable

Cleared under the same submission (K120010)

and 8 more cleared under K120010

Similar devices in this category

Other devices filed under Electrocardiographic lead set, reusable.

Other devices from Sensoronics Incorporated

See all devices from Sensoronics Incorporated →

Properties

  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (12, all answered No)