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 Spirometer, Monitoring (W/Wo Alarm)
510(k) Number K823783
Device Name RESPICOMB
Applicant
Respitrace Corp.
731 Saw Mill Rd.
Ardsley,  NY  10502
Applicant Contact WILLIAM GRUEN
Correspondent
Respitrace Corp.
731 Saw Mill Rd.
Ardsley,  NY  10502
Correspondent Contact WILLIAM GRUEN
Regulation Number868.1850
Classification Product Code
BZK  
Date Received12/15/1982
Decision Date 01/11/1984
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
-
-