510(k) K791633
K791633 is an FDA 510(k) premarket notification submitted by Life Support, Inc. for the device "UC-2000 UTERINE CATHERIZATION SYSTEM". The FDA issued a decision of Substantially Equivalent on September 17, 1979. The device falls under product code HFO (Recorder, Pressure, Intrauterine), a Class II device regulated under 21 CFR 884.2700. Life Support, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 1979
- Date Received
- August 21, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Recorder, Pressure, Intrauterine
- Device Class
- Class II
- Regulation Number
- 884.2700
- Review Panel
- OB
- Submission Type