The following data is part of a premarket notification filed by Albyn Medical Ltd. with the FDA for Gr100f Urine Flowmeter.
| Device ID | K971913 |
| 510k Number | K971913 |
| Device Name: | GR100F URINE FLOWMETER |
| Classification | Uroflowmeter |
| Applicant | ALBYN MEDICAL LTD. BRIDGEND ROAD IND'L ESTATE Dingwall, Ross-shire, GB Iv15 9qf |
| Contact | Ross K Maxwell |
| Correspondent | Ross K Maxwell ALBYN MEDICAL LTD. BRIDGEND ROAD IND'L ESTATE Dingwall, Ross-shire, GB Iv15 9qf |
| Product Code | EXY |
| CFR Regulation Number | 876.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-22 |
| Decision Date | 1997-09-19 |
| Summary: | summary |