Device Classification Name |
Ventilatory Effort Recorder
|
510(k) Number |
K963597 |
FOIA Releasable 510(k) |
K963597
|
Device Name |
SILENT NIGHT I |
Applicant |
LOCAL SILENCE, INC. |
935 FREMONT AVENUE, SUITE 115 |
LOS ALTOS,
CA
94024
|
|
Applicant Contact |
TONY MATOUK |
Correspondent |
LOCAL SILENCE, INC. |
935 FREMONT AVENUE, SUITE 115 |
LOS ALTOS,
CA
94024
|
|
Correspondent Contact |
TONY MATOUK |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 09/09/1996 |
Decision Date | 01/23/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|