Device Classification Name |
Monitor, Breathing Frequency
|
510(k) Number |
K923402 |
Device Name |
CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR |
Applicant |
PRO-TECH, INC. |
P.O. BOX 2165 |
17710-134TH AVENUE N.E. |
WOODINVILLE,
WA
98072
|
|
Applicant Contact |
RANDY CARRUTHERS |
Correspondent |
PRO-TECH, INC. |
P.O. BOX 2165 |
17710-134TH AVENUE N.E. |
WOODINVILLE,
WA
98072
|
|
Correspondent Contact |
RANDY CARRUTHERS |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 07/10/1992 |
Decision Date | 12/30/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|