510(k) K973850
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 1997
- Date Received
- October 8, 1997
- 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