510(k) K770579
K770579 is an FDA 510(k) premarket notification submitted by Life-Tech Instruments, Inc. for the device "CATHETER, URETHRAL PRESSURE, UPE-10 & 12". The FDA issued a decision of Substantially Equivalent on May 23, 1977. The device falls under product code FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device), a Class II device regulated under 21 CFR 876.1620. Life-Tech Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 1977
- Date Received
- March 28, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
- Device Class
- Class II
- Regulation Number
- 876.1620
- Review Panel
- GU
- Submission Type