The following data is part of a premarket notification filed by Respiratory Support Products, Inc. with the FDA for Foley Catheter Temperature Sensor.
| Device ID | K873448 |
| 510k Number | K873448 |
| Device Name: | FOLEY CATHETER TEMPERATURE SENSOR |
| Classification | Catheter, Urological |
| Applicant | RESPIRATORY SUPPORT PRODUCTS, INC. 3118 ALPINE Santa Ana, CA 92704 |
| Contact | Anthony V Beran |
| Correspondent | Anthony V Beran RESPIRATORY SUPPORT PRODUCTS, INC. 3118 ALPINE Santa Ana, CA 92704 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-26 |
| Decision Date | 1987-12-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019517061837 | K873448 | 000 |
| 35019517061820 | K873448 | 000 |
| 30695085000499 | K873448 | 000 |
| 30695085000482 | K873448 | 000 |
| 30695085000475 | K873448 | 000 |
| 30695085000468 | K873448 | 000 |