Device Classification Name |
cleaner, air, medical recirculating
|
510(k) Number |
K012549 |
Device Name |
ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM |
Applicant |
HEALTHWAY PRODUCTS, INC. |
PO BOX 2729 |
SYRACUSE,
NY
13220 -2729
|
|
Applicant Contact |
DICK BRIGGS |
Correspondent |
HEALTHWAY PRODUCTS, INC. |
PO BOX 2729 |
SYRACUSE,
NY
13220 -2729
|
|
Correspondent Contact |
DICK BRIGGS |
Regulation Number | 880.5045
|
Classification Product Code |
|
Date Received | 08/07/2001 |
Decision Date | 02/04/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|