510(k) K890284
- Device
- URODEC 500
- Applicant
- FERGUSON MEDICAL
- 510(k) number
- K890284
- Product code
- FES
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-05-30
- Date received
- 1989-01-19
- Regulation
- 876.1725
- Classification name
- Recorder, External, Pressure, Amplifier & Transducer
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- FRANK FERGUSON
- Address
- 3407 Bay Ave. Chico CA US 95973 95973
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FES #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K801757 | MMI/GAELTEC CATHETER TIP PRESS. TRANSDU | Medical Measurements, Inc. | 1980-08-27 |
Legacy Summary#
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FDA Review#
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