Device Classification Name |
Monitor, Breathing Frequency
|
510(k) Number |
K040605 |
Device Name |
DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100 |
Applicant |
DYMEDIX, INC. |
800 LEVANGER LN. |
STOUGHTON,
WI
53589
|
|
Applicant Contact |
Gary Syring |
Correspondent |
DYMEDIX, INC. |
800 LEVANGER LN. |
STOUGHTON,
WI
53589
|
|
Correspondent Contact |
Gary Syring |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 03/08/2004 |
Decision Date | 04/26/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|