Device Classification Name |
heater, breathing system w/wo controller (not humidifier or nebulizer
|
510(k) Number |
K880769 |
Device Name |
BREATHING CIRCUIT W/HEATED WIRE |
Applicant |
DRYDEN CORP. |
10640 EAST 59TH ST. |
P.O. BOX 36038 |
INDIANAPOLIS,
IN
46236
|
|
Applicant Contact |
PAUL E DRYDEN |
Correspondent |
DRYDEN CORP. |
10640 EAST 59TH ST. |
P.O. BOX 36038 |
INDIANAPOLIS,
IN
46236
|
|
Correspondent Contact |
PAUL E DRYDEN |
Regulation Number | 868.5270
|
Classification Product Code |
|
Date Received | 02/29/1988 |
Decision Date | 08/24/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|