Device Classification Name |
Monitor, Apnea, Facility Use
|
510(k) Number |
K822077 |
Device Name |
RESPIRATION MONITOR TYPE MR-10 |
Applicant |
NEW DIMENSIONS IN MEDICINE, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
NEW DIMENSIONS IN MEDICINE, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 868.2377
|
Classification Product Code |
|
Date Received | 07/15/1982 |
Decision Date | 10/06/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|