510(k) K871079
K871079 is an FDA 510(k) premarket notification submitted by Epcom Medical Systems, Inc. for the device "FETALFLEX FETAL ELECTRODE". The FDA issued a decision of Substantially Equivalent on July 13, 1987. The device falls under product code HGP (Electrode, Circular (Spiral), Scalp And Applicator), a Class II device regulated under 21 CFR 884.2675. Epcom Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 13, 1987
- Date Received
- March 18, 1987
- 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