Device Classification Name |
Spirometer, Diagnostic
|
510(k) Number |
K904947 |
Device Name |
PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE |
Applicant |
PLANMECA USA, INC. |
ASENTAJASNKATU 6 |
00810 HELSINKI |
FINLAND,
FI
|
|
Applicant Contact |
MATTI SPOLANDER |
Correspondent |
PLANMECA USA, INC. |
ASENTAJASNKATU 6 |
00810 HELSINKI |
FINLAND,
FI
|
|
Correspondent Contact |
MATTI SPOLANDER |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 11/01/1990 |
Decision Date | 01/30/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|