Device Classification Name |
Mixer, Breathing Gases, Anesthesia Inhalation
|
510(k) Number |
K811393 |
Device Name |
DOWNS CAP FLOW GENERATOR |
Applicant |
VITAL SIGNS, INC. |
1 MADISON ST. |
EAST RUTHERFORD,
NJ
07073
|
|
Applicant Contact |
Terence D Wall |
Correspondent |
VITAL SIGNS, INC. |
1 MADISON ST. |
EAST RUTHERFORD,
NJ
07073
|
|
Correspondent Contact |
Terence D Wall |
Regulation Number | 868.5330
|
Classification Product Code |
|
Date Received | 05/18/1981 |
Decision Date | 06/09/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|