The following data is part of a premarket notification filed by Joseph F. Daniel, C.r.n.a. with the FDA for Uritron Urine Meter.
Device ID | K790894 |
510k Number | K790894 |
Device Name: | URITRON URINE METER |
Classification | Device, Urine Flow Rate Measuring, Non-electrical, Disposable |
Applicant | JOSEPH F. DANIEL, C.R.N.A. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FFG |
CFR Regulation Number | 876.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-05-08 |
Decision Date | 1979-09-07 |