The following data is part of a premarket notification filed by Fiberoptic Sensor Technlogies, Inc. with the FDA for 4-channel Urodynamic Monitor With Uro-flo Option.
| Device ID | K945495 |
| 510k Number | K945495 |
| Device Name: | 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION |
| Classification | Uroflowmeter |
| Applicant | FIBEROPTIC SENSOR TECHNLOGIES, INC. 501 AVIS DR. Ann Arbor, MI 48108 |
| Contact | Gary C Simpson |
| Correspondent | Gary C Simpson FIBEROPTIC SENSOR TECHNLOGIES, INC. 501 AVIS DR. Ann Arbor, MI 48108 |
| Product Code | EXY |
| CFR Regulation Number | 876.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-08 |
| Decision Date | 1995-02-09 |