SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF— 510(k) K020910
Substantially EquivalentThe Electrode Store, Inc.
FDA 510(k) clearance K020910 for SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF, Substantially Equivalent on 2002-07-19. Applicant: The Electrode Store, Inc.. Device class: 2.
Clearance details
- Applicant
- The Electrode Store, Inc.
- Product code
- Code GXZ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1350
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seattle, WA, US
Recent devices under product code GXZ
view allMore clearances from The Electrode Store, Inc.
view all- K083758 — SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS
- K022197 — SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY
- K020445 — THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG
- K926094 — PROTECTRODE SYSTEM
- K932691 — PROTECTRODE SYSTEMS CONCENTRIC
Data sourced from openFDA. This site is unofficial and independent of the FDA.