Device Classification Name |
Monitor, Breathing Frequency
|
510(k) Number |
K801894 |
Device Name |
RESPONDER II |
Applicant |
CLINICAL MICROSYSTEMS INTL. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
CLINICAL MICROSYSTEMS INTL. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 08/08/1980 |
Decision Date | 08/27/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|