The following data is part of a premarket notification filed by Yellow Springs Instrument Co., Inc. with the FDA for Ysi Models 4700 Foley Catheter Temperature Probes.
| Device ID | K922821 |
| 510k Number | K922821 |
| Device Name: | YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBES |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | YELLOW SPRINGS INSTRUMENT CO., INC. 1725 BRANNUM LN. Yellow Springs, OH 45387 |
| Contact | Fred Breidt |
| Correspondent | Fred Breidt YELLOW SPRINGS INSTRUMENT CO., INC. 1725 BRANNUM LN. Yellow Springs, OH 45387 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-11 |
| Decision Date | 1992-11-23 |