Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K944175 |
Device Name |
ADAM SHELL THERMOCOUPLE ASSEMBLY |
Applicant |
PRO-TECH SERVICES, INC. |
17710-134TH AVE N.E. |
P.O BOX 2165 |
WOODINVILLE,
WA
98072
|
|
Applicant Contact |
RANDY CARRUTHERS |
Correspondent |
PRO-TECH SERVICES, INC. |
17710-134TH AVE N.E. |
P.O BOX 2165 |
WOODINVILLE,
WA
98072
|
|
Correspondent Contact |
RANDY CARRUTHERS |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 08/26/1994 |
Decision Date | 10/14/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|