• 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 system, imaging, pulsed doppler, ultrasonic
510(k) Number K211232
Device Name Apache Ultrasound System
Applicant
Aco Healthcare Co,. Ltd.
Rm. 520, Bldg. 53, No. 195, Sec. 4, Chungshin Rd., Chutung
hsinchu,  TW 31057
Applicant Contact henry huang
Correspondent
Aco Healthcare Co,. Ltd.
Rm. 520, Bldg. 53, No. 195, Sec. 4, Chungshin Rd., Chutung
hsinchu,  TW 31057
Correspondent Contact henry huang
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received04/23/2021
Decision Date 06/25/2021
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-