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 K896923
Device Name INTERTECH/INSPIRON (R) MEDICATION NEBULIZER KIT
Applicant
INTERTECH RESOURCES, INC.
5100 TICE ST.
FT. MYERS,  FL  33905
Applicant Contact JAMES POPE
Correspondent
INTERTECH RESOURCES, INC.
5100 TICE ST.
FT. MYERS,  FL  33905
Correspondent Contact JAMES POPE
Regulation Number868.5630
Classification Product Code
CAF  
Date Received12/12/1989
Decision Date 03/12/1990
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
-
-