| Device Classification Name |
Continuous Measurement Thermometer
|
| 510(k) Number |
K962070 |
| Device Name |
YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE |
| Applicant |
| Yellow Springs Instrument Co., Inc. |
| 1725 Brannum Ln |
|
Yellow Springs,
OH
45387
|
|
| Applicant Contact |
JAMES R GRAVER |
| Correspondent |
| Yellow Springs Instrument Co., Inc. |
| 1725 Brannum Ln |
|
Yellow Springs,
OH
45387
|
|
| Correspondent Contact |
JAMES R GRAVER |
| Regulation Number | 880.2910 |
| Classification Product Code |
|
| Date Received | 05/28/1996 |
| Decision Date | 07/19/1996 |
| 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
|
| Recalls |
CDRH Recalls
|
|
|