Device Classification Name |
Ventilatory Effort Recorder
|
510(k) Number |
K110486 |
Device Name |
ACCUSOM |
Applicant |
NOVASOM, INC. |
801 CROMWELL PARK DRIVE |
GLEN BURNIE,
MD
21061
|
|
Applicant Contact |
ROGER K RICHARDSON |
Correspondent |
NOVASOM, INC. |
801 CROMWELL PARK DRIVE |
GLEN BURNIE,
MD
21061
|
|
Correspondent Contact |
ROGER K RICHARDSON |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 02/22/2011 |
Decision Date | 08/12/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|