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 Oximeter
510(k) Number K231531
Device Name Pediarity™
Applicant
Hinlab, Inc.
412 Canary Court
Lewes,  DE  19958
Applicant Contact Denys-Michel de Larouziere
Correspondent
Hinlab, Inc.
412 Canary Court
Lewes,  DE  19958
Correspondent Contact Denys-Michel de Larouziere
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
DRG  
Date Received05/26/2023
Decision Date 12/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-