• 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 K911192
Device Name DP 100
Applicant
FERGUSON MEDICAL
3407 BAY AVE.
CHICO,  CA  95973 -8619
Applicant Contact FRANK FERGUSON
Correspondent
FERGUSON MEDICAL
3407 BAY AVE.
CHICO,  CA  95973 -8619
Correspondent Contact FRANK FERGUSON
Regulation Number868.5630
Classification Product Code
CAF  
Date Received03/18/1991
Decision Date 12/11/1991
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
-
-