Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K834475 |
Device Name |
RESPIRODYNE PULMONARY FUNCTION TEST |
Applicant |
CHESEBROUGH-POND'S U.S.A. CO. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
CHESEBROUGH-POND'S U.S.A. CO. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 12/20/1983 |
Decision Date | 02/17/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|