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 nebulizer (direct patient interface)
510(k) Number K960675
Device Name WALKHALER PORTABLE COMPRESSOR MODEL 45F70
Applicant
PARI HOLDING CO.
7493 WHITEPINE RD.
RICHMOND,  VA  23237
Applicant Contact MIGUEL A ARRIZON
Correspondent
PARI HOLDING CO.
7493 WHITEPINE RD.
RICHMOND,  VA  23237
Correspondent Contact MIGUEL A ARRIZON
Regulation Number868.5630
Classification Product Code
CAF  
Date Received02/20/1996
Decision Date 05/17/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-