510(k) K954955
K954955 is an FDA 510(k) premarket notification submitted by Clinical Innovations, Inc. for the device "STORC INTRAUTERINE PRESSURE CATHETER". The FDA issued a decision of Substantially Equivalent on April 17, 1996. The device falls under product code HFN (Transducer, Pressure, Intrauterine), a Class II device regulated under 21 CFR 884.2700. Clinical Innovations, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 1996
- Date Received
- October 27, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Pressure, Intrauterine
- Device Class
- Class II
- Regulation Number
- 884.2700
- Review Panel
- OB
- Submission Type