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Amc Kt-SA-1187-36-05

by LifeSync Corporation 2 variants

Amc Kt-SA-1187-36-05 is a Class II device made by LifeSync Corporation, cleared under FDA 510(k) K992524 on 1 Mar 2000 and listed in FDA GUDID since 15 Oct 2020 (UDI-DI 00849593017862), active as of 23 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 23 Oct 2026

Documents

510(k) K992524

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00849593017862 UDI-DI Date15 Oct 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK992524 Date1 Mar 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K992524 decided 1 Mar 2000 Active
  • FDA GUDID UDI-DI 00849593017862 listed 15 Oct 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K992524
  2. Listed FDA GUDID 00849593017862

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Amc
Generic name
Electrocardiographic lead set, reusable
Model / reference
KT-SA-1187-36-05
Primary DI / UDI-DI
00849593017862
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
MRI safety
MR Unsafe

Related devices

Category: Electrocardiographic lead set, reusable

Cleared under the same submission (K992524)

and 8 more cleared under K992524

Similar devices in this category

Other devices filed under Electrocardiographic lead set, reusable.

Other devices from LifeSync Corporation

See all devices from LifeSync Corporation →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)