510(k) K801758
K801758 is an FDA 510(k) premarket notification submitted by Medical Measurements, Inc. for the device "MMI/GAELTEC CATHETER INTRAUTERINE". The FDA issued a decision of Substantially Equivalent on August 14, 1980. The device falls under product code KXO (Monitor, Pressure, Intrauterine), a Class II device regulated under 21 CFR 884.2700. Medical Measurements, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 14, 1980
- Date Received
- July 28, 1980
- 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