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 K872631
Device Name INFANT MONITOR, MODEL 2400
Applicant
Arvee Medical, Inc.
730 E. Michigan Ave.
Battle Creek,  MI  49016
Applicant Contact KUMAR KULKARNI
Correspondent
Arvee Medical, Inc.
730 E. Michigan Ave.
Battle Creek,  MI  49016
Correspondent Contact KUMAR KULKARNI
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received07/06/1987
Decision Date 10/26/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-