DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A


definition

Device Classification Name

cleaner, air, medical recirculating

510(k) Number K002692
Device Name DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A
Original Applicant
HMI INDUSTRIES, INC.
13325 darice pkwy.
strongville, 
OH 
44149

Original Contact jacqueline a purcell
Regulation Number 880.5045
Classification Product Code
FRF  
Date Received 08/29/2000
Decision Date 11/17/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized