Device Classification Name |
ventilatory effort recorder
|
510(k) Number |
K080321 |
Device Name |
SNAP MODEL 7 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM |
Applicant |
SNAP LABORATORIES, L.L.C. |
5210 CAPITOL DRIVE |
WHEELING,
IL
60090
|
|
Applicant Contact |
GIL RAVIV |
Correspondent |
SNAP LABORATORIES, L.L.C. |
5210 CAPITOL DRIVE |
WHEELING,
IL
60090
|
|
Correspondent Contact |
GIL RAVIV |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 02/06/2008 |
Decision Date | 05/23/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|