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 chamber, hyperbaric
510(k) Number K840841
Device Name RENEAU UNIT
Applicant
RENEAU, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
RENEAU, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5470
Classification Product Code
CBF  
Date Received02/24/1984
Decision Date 08/07/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-