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 Arterial Blood Sampling Kit
510(k) Number K930986
Device Name BLOOD GAS KIT (NON-STERILE) REORDER NO. 0560
Applicant
CUSTOMED, INC.
CALLE IGUALDAD #7
FAJARDO,  PR  00738
Applicant Contact FELIX B SANTOS
Correspondent
CUSTOMED, INC.
CALLE IGUALDAD #7
FAJARDO,  PR  00738
Correspondent Contact FELIX B SANTOS
Regulation Number868.1100
Classification Product Code
CBT  
Date Received02/25/1993
Decision Date 07/14/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-