The following data is part of a premarket notification filed by Respiratory Support Products, Inc. with the FDA for Urine Meter Foley Tray With Temperature Sensor.
| Device ID | K903816 |
| 510k Number | K903816 |
| Device Name: | URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR |
| Classification | Catheter, Retention Type |
| Applicant | RESPIRATORY SUPPORT PRODUCTS, INC. 2552 MCGAW AVE. Irvine, CA 92614 |
| Contact | Kerry J Tomic |
| Correspondent | Kerry J Tomic RESPIRATORY SUPPORT PRODUCTS, INC. 2552 MCGAW AVE. Irvine, CA 92614 |
| Product Code | EZK |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-20 |
| Decision Date | 1990-10-31 |