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 mixer, breathing gases, anesthesia inhalation
510(k) Number K952021
Device Name PRIMA HYUPERINFLATION SYSTEM
Applicant
PRIMA, INC.
1300 25TH ST. PLAZA
SUITE 11
CLEVELAND,  TN  37311
Applicant Contact ROBERT STEINBARGER
Correspondent
PRIMA, INC.
1300 25TH ST. PLAZA
SUITE 11
CLEVELAND,  TN  37311
Correspondent Contact ROBERT STEINBARGER
Regulation Number868.5330
Classification Product Code
BZR  
Date Received04/28/1995
Decision Date 05/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-