510(k) K961290
K961290 is an FDA 510(k) premarket notification submitted by Scientific Device Manufacturer, LLC for the device "IUP - TIP TRANS, IUP - PROXI TRANS". The FDA issued a decision of Substantially Equivalent on October 15, 1996. The device falls under product code KXO (Monitor, Pressure, Intrauterine), a Class II device regulated under 21 CFR 884.2700. Scientific Device Manufacturer, LLC has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 15, 1996
- Date Received
- April 4, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Pressure, Intrauterine
- Device Class
- Class II
- Regulation Number
- 884.2700
- Review Panel
- OB
- Submission Type