510(k) K801984
K801984 is an FDA 510(k) premarket notification submitted by Life Support, Inc. for the device "FE-3000 FETAL ELECTRODE, SPIRAL SYSTEM". The FDA issued a decision of Substantially Equivalent on September 9, 1980. The device falls under product code HGP (Electrode, Circular (Spiral), Scalp And Applicator), a Class II device regulated under 21 CFR 884.2675. Life Support, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 1980
- Date Received
- August 19, 1980
- 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