Device Classification Name |
spirometer, monitoring (w/wo alarm)
|
510(k) Number |
K852692 |
Device Name |
RESPITRACE 300SC |
Applicant |
RESPITRACE CORP. |
731 SAW MILL RD. |
ARDSLEY,
NY
10502
|
|
Applicant Contact |
WILLIAM GRUEN |
Correspondent |
RESPITRACE CORP. |
731 SAW MILL RD. |
ARDSLEY,
NY
10502
|
|
Correspondent Contact |
WILLIAM GRUEN |
Regulation Number | 868.1850
|
Classification Product Code |
|
Date Received | 06/26/1985 |
Decision Date | 07/15/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|