Device Classification Name |
Stimulator, Nerve, Peripheral, Electric
|
510(k) Number |
K051635 |
Device Name |
DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES |
Applicant |
GE HEALTHCARE |
86 PILGRIM ROAD |
NEEDHAM,
MA
02492
|
|
Applicant Contact |
JOEL C KENT |
Correspondent |
GE HEALTHCARE |
86 PILGRIM ROAD |
NEEDHAM,
MA
02492
|
|
Correspondent Contact |
JOEL C KENT |
Regulation Number | 868.2775
|
Classification Product Code |
|
Date Received | 06/20/2005 |
Decision Date | 07/15/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|