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 Ventilator, Continuous, Facility Use
510(k) Number K802583
Device Name INFANT VENTILATOR, (RESPIRATOR) PLAN B
Applicant
Healthdyne, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Healthdyne, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.5895
Classification Product Code
CBK  
Date Received10/20/1980
Decision Date 12/18/1980
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
-
-