The following data is part of a premarket notification filed by Aspen Medical Ltd. with the FDA for Phoenix 5 Urodynamics System.
| Device ID | K914300 |
| 510k Number | K914300 |
| Device Name: | PHOENIX 5 URODYNAMICS SYSTEM |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | ASPEN MEDICAL LTD. BRIDGEND RD. INDUSTRIAL ESTATE DINGWALL, ROSS-SHIRE IV15 9QF Scotland, GB |
| Contact | Ross K Maxwell |
| Correspondent | Ross K Maxwell ASPEN MEDICAL LTD. BRIDGEND RD. INDUSTRIAL ESTATE DINGWALL, ROSS-SHIRE IV15 9QF Scotland, GB |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-25 |
| Decision Date | 1992-06-02 |