| Device Classification Name |
Continuous Measurement Thermometer
|
| 510(k) Number |
K883793 |
| Device Name |
DISPOSABLE TEMPERATURE PROBES (SEVERAL MODELS) |
| Applicant |
| Yellow Springs Instrument Co., Inc. |
| 1725 Brannum Ln. |
|
Yellow Springs,
OH
45387
|
|
| Applicant Contact |
FRED BREIDT |
| Correspondent |
| Yellow Springs Instrument Co., Inc. |
| 1725 Brannum Ln. |
|
Yellow Springs,
OH
45387
|
|
| Correspondent Contact |
FRED BREIDT |
| Regulation Number | 880.2910 |
| Classification Product Code |
|
| Date Received | 09/07/1988 |
| Decision Date | 11/21/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|