TENZCARE MUSCLE STIMULATION ELECTRODES— 510(k) K831104
Substantially Equivalent3M Company
FDA 510(k) clearance K831104 for TENZCARE MUSCLE STIMULATION ELECTRODES, Substantially Equivalent on 1983-05-09. Applicant: 3M Company. Device class: 2.
Clearance details
- Applicant
- 3M Company
- 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
- White City, OR, US
Recent devices under product code GXY
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- K261442 — Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array
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- K253237 — Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
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- K241710 — 3M Attest Super Rapid Readout Biological Indicator 1492V +3 more
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Data sourced from openFDA. This site is unofficial and independent of the FDA.