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 K880304
Device Name INSPIRON NEBULO BASIC EXTERNAL HEATER
Applicant
INTERTECH RESOURCES, INC.
333 WEST WACKER DR.
SUITE 1900
CHICAGO,  IL  60606
Applicant Contact SHERYL MARCOUILLER
Correspondent
INTERTECH RESOURCES, INC.
333 WEST WACKER DR.
SUITE 1900
CHICAGO,  IL  60606
Correspondent Contact SHERYL MARCOUILLER
Regulation Number868.5630
Classification Product Code
CAF  
Date Received01/25/1988
Decision Date 03/04/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-