The following data is part of a premarket notification filed by Ysis, Inc with the FDA for Ysi Models 4400 Foley Catheter Temperature Probes.
| Device ID | K921561 |
| 510k Number | K921561 |
| Device Name: | YSI MODELS 4400 FOLEY CATHETER TEMPERATURE PROBES |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | YSIS, INC 1725 BRANNUM LN. Yellow Springs, OH 45387 -0279 |
| Contact | Fred Breidt |
| Correspondent | Fred Breidt YSIS, INC 1725 BRANNUM LN. Yellow Springs, OH 45387 -0279 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-01 |
| Decision Date | 1992-11-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884838008650 | K921561 | 000 |
| 20884838006922 | K921561 | 000 |
| 20884838006915 | K921561 | 000 |