The following data is part of a premarket notification filed by Yellow Springs Instrument Co., Inc. with the FDA for Ysi 400 Series Atuoclavable Reusable Temperature Probe.
| Device ID | K962070 |
| 510k Number | K962070 |
| Device Name: | YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | YELLOW SPRINGS INSTRUMENT CO., INC. 1725 BRANNUM LN. Yellow Springs, OH 45387 |
| Contact | James R Graver |
| Correspondent | James R Graver YELLOW SPRINGS INSTRUMENT CO., INC. 1725 BRANNUM LN. Yellow Springs, OH 45387 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-28 |
| Decision Date | 1996-07-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10803622140225 | K962070 | 000 |
| 00803622133145 | K962070 | 000 |
| 00884838008069 | K962070 | 000 |
| 00884838008052 | K962070 | 000 |
| 00884838008045 | K962070 | 000 |
| 00884838001015 | K962070 | 000 |
| 00884838001008 | K962070 | 000 |
| 00884838000995 | K962070 | 000 |