Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K242583
Device Name AT-Patch (ATP-C130/ATP-C70)
Applicant
Atsens Co., Ltd.
Point Town 803, 11, Gumi-Ro, Bundang-Gu,
Seongnam-Si, Gyeonggi-Do
Seongnam-Si,  KR 13637
Applicant Contact KeonHoon Lee
Correspondent
Bt Solutions, Inc.
Unit 303, 337, Gonghang-Daero, Gangseo-Gu
Seoul,  KR 07590
Correspondent Contact Do Hyun Kim
Regulation Number870.2800
Classification Product Code
DSH  
Subsequent Product Code
DQK  
Date Received08/30/2024
Decision Date 05/02/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-