| Device Classification Name |
Monitor, Breathing Frequency
|
| 510(k) Number |
K960851 |
| Device Name |
THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSOR |
| Applicant |
| Pro-Tech Services, Inc. |
| 12826 NW 178th St., Suite A |
|
Woodinville,
WA
98072
|
|
| Applicant Contact |
ANTHONY ZARAGOZA |
| Correspondent |
| Pro-Tech Services, Inc. |
| 12826 NW 178th St., Suite A |
|
Woodinville,
WA
98072
|
|
| Correspondent Contact |
ANTHONY ZARAGOZA |
| Regulation Number | 868.2375 |
| Classification Product Code |
|
| Date Received | 03/01/1996 |
| Decision Date | 09/17/1996 |
| Decision |
SE SUBJECT TO TRACKING REG
(ST) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|