Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K922314 |
Device Name |
VENTILATOR INTERFACE 9291/4 |
Applicant |
S & W MEDICO TEKNIK |
HERSTEDVANG 8 |
DK-2620 ALBERTSLUND |
DENMARK,
DK
|
|
Applicant Contact |
MORTEN NIELSON |
Correspondent |
S & W MEDICO TEKNIK |
HERSTEDVANG 8 |
DK-2620 ALBERTSLUND |
DENMARK,
DK
|
|
Correspondent Contact |
MORTEN NIELSON |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 05/18/1992 |
Decision Date | 12/17/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|