| Device Classification Name |
Stimulator, Nerve, Battery-Powered
|
| 510(k) Number |
K862149 |
| Device Name |
MODIFIED NEUROMUSCULAR TRANSMISSION MONITOR |
| Applicant |
| Puritan Bennett Corp. |
| 9401 Indian Creek Pkwy. |
| P.O. Box 25905 |
|
Overland Park,
KS
66225
|
|
| Applicant Contact |
HARTLEY C ERICSON |
| Correspondent |
| Puritan Bennett Corp. |
| 9401 Indian Creek Pkwy. |
| P.O. Box 25905 |
|
Overland Park,
KS
66225
|
|
| Correspondent Contact |
HARTLEY C ERICSON |
| Regulation Number | 868.2775 |
| Classification Product Code |
|
| Date Received | 06/04/1986 |
| Decision Date | 06/19/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|