510(k) K801757
- Device
- MMI/GAELTEC CATHETER TIP PRESS. TRANSDU
- Applicant
- MEDICAL MEASUREMENTS, INC.
- 510(k) number
- K801757
- Product code
- FES
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-08-27
- Date received
- 1980-07-28
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FES #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K890284 | URODEC 500 | Ferguson Medical | 1989-05-30 |
Legacy Summary#
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FDA Review#
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