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 analyzer, gas, carbon-dioxide, gaseous-phase
510(k) Number K150272
Device Name Capnostream 35 Portable Respiratory Monitor
Applicant
ORIDION MEDICAL 1987 LTD.
7 HAMARPE ST.
JERUSALEM,  IL 9777407
Applicant Contact Dalia Givony
Correspondent
ORIDION MEDICAL 1987 LTD.
7 HAMARPE ST.
JERUSALEM,  IL 9777407
Correspondent Contact Dalia Givony
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Codes
DQA   MNR  
Date Received02/04/2015
Decision Date 07/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-