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 Monitor, Breathing Frequency
510(k) Number K100773
Device Name KAI SPOT MODEL KMS 200
Applicant
Kai Medical, Inc.
3465 Waialae Ave.
Suite 370
Honolulu,  HI  96816
Applicant Contact ROBERT NAKATA
Correspondent
Kai Medical, Inc.
3465 Waialae Ave.
Suite 370
Honolulu,  HI  96816
Correspondent Contact ROBERT NAKATA
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received03/18/2010
Decision Date 06/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-