510(k) K792669
K792669 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Information Technologies for the device "COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE". The FDA issued a decision of Substantially Equivalent on February 11, 1980. The device falls under product code HGP (Electrode, Circular (Spiral), Scalp And Applicator), a Class II device regulated under 21 CFR 884.2675. Ge Medical Systems Information Technologies has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 11, 1980
- Date Received
- December 27, 1979
- 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