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 |