Device Classification Name |
Ventilatory Effort Recorder
|
510(k) Number |
K022294 |
Device Name |
APNEACHECK |
Applicant |
IM SYSTEMS |
1055 TAYLOR AVE. |
SUITE 300 |
BALTIMORE,
MD
21286
|
|
Applicant Contact |
DAVID T KRAUSMAN |
Correspondent |
IM SYSTEMS |
1055 TAYLOR AVE. |
SUITE 300 |
BALTIMORE,
MD
21286
|
|
Correspondent Contact |
DAVID T KRAUSMAN |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 07/16/2002 |
Decision Date | 04/25/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|