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 Needle, Hypodermic, Single Lumen
510(k) Number K211968
Device Name NIO+ Adult
Applicant
Waismed, Ltd.
10 Amal St. Afek Industrial Park
Rosh Ha'Ayin,  IL 4809234
Applicant Contact Shifra Hoch
Correspondent
Waismed, Ltd.
10 Amal St. Afek Industrial Park
Rosh Ha'Ayin,  IL 4809234
Correspondent Contact Shifra Hoch
Regulation Number880.5570
Classification Product Code
FMI  
Date Received06/24/2021
Decision Date 07/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-