The following data is part of a premarket notification filed by Gyrus Medical Ltd. with the FDA for Dilectron Urinary Conductivity Probe.
| Device ID | K891681 |
| 510k Number | K891681 |
| Device Name: | DILECTRON URINARY CONDUCTIVITY PROBE |
| Classification | Refractometer For Clinical Use |
| Applicant | GYRUS MEDICAL LTD. CHAPEL COTTAGE MILTON COMBE YELVERTON DEVON PL20 6HP England, GB |
| Contact | Goble |
| Correspondent | Goble GYRUS MEDICAL LTD. CHAPEL COTTAGE MILTON COMBE YELVERTON DEVON PL20 6HP England, GB |
| Product Code | JRE |
| CFR Regulation Number | 862.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-22 |
| Decision Date | 1990-05-01 |