Device Classification Name |
Monitor, Breathing Frequency
|
510(k) Number |
K811265 |
Device Name |
RESPIRATORY SENSOR (MODEL 409 W/NASOPH.) |
Applicant |
IMPACT INSTRUMENTATION, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
IMPACT INSTRUMENTATION, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 05/12/1981 |
Decision Date | 06/02/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|