Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K861227 |
Device Name |
COLLINS PNEUMOTACH PFT SYSTEM |
Applicant |
WARREN E. COLLINS, INC. |
220 WOOD RD. |
BRAINTREE,
MA
02184 -2408
|
|
Applicant Contact |
JAMES TULLY |
Correspondent |
WARREN E. COLLINS, INC. |
220 WOOD RD. |
BRAINTREE,
MA
02184 -2408
|
|
Correspondent Contact |
JAMES TULLY |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 04/01/1986 |
Decision Date | 06/05/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|