510(k) K011840
K011840 is an FDA 510(k) premarket notification submitted by Cervilenz, Inc. for the device "CERVILENZ UTERINE MEASURING SOUND". The FDA issued a decision of Substantially Equivalent on Aug 10, 2001. The device falls under product code HHM (Sound, Uterine), a Class I device regulated under 21 CFR 884.4530.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 10, 2001
- Date Received
- Jun 12, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Sound, Uterine
- Device Class
- Class I
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type
- 510(k) Exempt