Device Classification Name |
Stimulator, Nerve, Battery-Powered
|
510(k) Number |
K893485 |
Device Name |
ACCELOGRAPH NEUROMUSCULAR TRANSMISSION MONITOR |
Applicant |
BIOMETER INTL. A/S |
21 A/ HANS EGEDESVEJ |
DK- - 5210 ODENSE NV |
DENMARK,
DK
|
|
Applicant Contact |
FLEMMING HIMMELSTRUP |
Correspondent |
BIOMETER INTL. A/S |
21 A/ HANS EGEDESVEJ |
DK- - 5210 ODENSE NV |
DENMARK,
DK
|
|
Correspondent Contact |
FLEMMING HIMMELSTRUP |
Regulation Number | 868.2775
|
Classification Product Code |
|
Date Received | 05/04/1989 |
Decision Date | 07/28/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|