| Device Classification Name |
System, Environmental Control, Powered
|
| 510(k) Number |
K873612 |
| Device Name |
IMSI, VITAL CALL |
| Applicant |
| Intl. Management Services, Inc. |
| P.O. Box 82224 |
|
Lincoln,
NE
68501
|
|
| Applicant Contact |
JOHN J BRASCH |
| Correspondent |
| Intl. Management Services, Inc. |
| P.O. Box 82224 |
|
Lincoln,
NE
68501
|
|
| Correspondent Contact |
JOHN J BRASCH |
| Regulation Number | 890.3725 |
| Classification Product Code |
|
| Date Received | 09/08/1987 |
| Decision Date | 11/23/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Physical Medicine
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|