Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K910452 |
Device Name |
RESPI-PAK RT-PAK |
Applicant |
CNS, INC. |
7090 SHADY OAK RD. |
EDEN PRAIRIE,
MN
55344
|
|
Applicant Contact |
JOHN F STOLTE |
Correspondent |
CNS, INC. |
7090 SHADY OAK RD. |
EDEN PRAIRIE,
MN
55344
|
|
Correspondent Contact |
JOHN F STOLTE |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 02/01/1991 |
Decision Date | 04/16/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|