Device Classification Name |
Ventilatory Effort Recorder
|
510(k) Number |
K990321 |
Device Name |
ALPHAMED GEMINI SENSOR, SNORING SENSOR |
Applicant |
ALPHAMED, INC. |
3989 CENTRAL AVE. NE |
SUITE 560 |
MINNEAPOLIS,
MN
55421
|
|
Applicant Contact |
PETER STASE |
Correspondent |
ALPHAMED, INC. |
3989 CENTRAL AVE. NE |
SUITE 560 |
MINNEAPOLIS,
MN
55421
|
|
Correspondent Contact |
PETER STASE |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 02/01/1999 |
Decision Date | 06/01/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|