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 Incubator, Neonatal
510(k) Number K781876
Device Name ISOLETTE INCUBATOR
Applicant
Air-Shields, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Air-Shields, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5400
Classification Product Code
FMZ  
Date Received11/02/1978
Decision Date 12/07/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-