ELECTRODE USING PROMEON RG-60 SERIES GEL— 510(k) K915333
Substantially EquivalentLabeltape Meditect, Inc.
FDA 510(k) clearance K915333 for ELECTRODE USING PROMEON RG-60 SERIES GEL, Substantially Equivalent on 1992-01-14. Applicant: Labeltape Meditect, Inc.. Device class: 2.
Clearance details
- Applicant
- Labeltape Meditect, 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
- Grand Rapids, MI, US
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Recalls naming K915333
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K915333.
Data sourced from openFDA. This site is unofficial and independent of the FDA.