510(k) K030691
K030691 is an FDA 510(k) premarket notification submitted by Clinical Innovations, Inc. for the device "FETAL SPIRAL ELECTRODE, MODEL FSE07000". The FDA issued a decision of Substantially Equivalent on September 17, 2003. The device falls under product code HGP (Electrode, Circular (Spiral), Scalp And Applicator), a Class II device regulated under 21 CFR 884.2675. Clinical Innovations, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 2003
- Date Received
- March 5, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Circular (Spiral), Scalp And Applicator
- Device Class
- Class II
- Regulation Number
- 884.2675
- Review Panel
- OB
- Submission Type