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 Cleaner, Air, Medical Recirculating
510(k) Number K010616
Device Name DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A
Applicant
HMI INDUSTRIES, INC.
13325 DARICE PKWY.
STRONGVILLE,  OH  44149
Applicant Contact JACQUELINE PERCELL
Correspondent
HMI INDUSTRIES, INC.
13325 DARICE PKWY.
STRONGVILLE,  OH  44149
Correspondent Contact JACQUELINE PERCELL
Regulation Number880.5045
Classification Product Code
FRF  
Date Received03/01/2001
Decision Date 03/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
-
-