GOLD CUP EEG CUTANEOUS ELECTRODE W/LEAD AND EXT.— 510(k) K911989
Substantially EquivalentSomnitec, Inc.
FDA 510(k) clearance K911989 for GOLD CUP EEG CUTANEOUS ELECTRODE W/LEAD AND EXT., Substantially Equivalent on 1991-07-30. Applicant: Somnitec, Inc.. Device class: 2.
Clearance details
- Applicant
- Somnitec, Inc.
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Van Nuys, CA, US
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view allData sourced from openFDA. This site is unofficial and independent of the FDA.