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 K900314
Device Name PERCUSSIONAIRE(R) OSCILLATRON-1 PERCUSS 1300 MIN
Applicant
PERCUSSIONAIRE CORP.
BIRD AIRLODGE, GLENGARY BAY
P.O. BOX 817
SANDPOINT,  ID  83864
Applicant Contact BIRD, MD
Correspondent
PERCUSSIONAIRE CORP.
BIRD AIRLODGE, GLENGARY BAY
P.O. BOX 817
SANDPOINT,  ID  83864
Correspondent Contact BIRD, MD
Regulation Number868.5895
Classification Product Code
CBK  
Date Received01/22/1990
Decision Date 10/26/1990
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-