REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS— 510(k) K921504
Substantially EquivalentChalgren Enterprises, Inc.
FDA 510(k) clearance K921504 for REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS, Substantially Equivalent on 1992-09-11. Applicant: Chalgren Enterprises, Inc.. Device class: 2.
Clearance details
- Applicant
- Chalgren Enterprises, Inc.
- Product code
- Code JXE
- Device class
- Class 2
- Regulation
- 21 CFR 882.1550
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gilroy, CA, US
Recent devices under product code JXE
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- K955335 — DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE
- K953354 — EMG DISC RECORDING ELECTRODE
- K953356 — EMG RECORDING RING ELECTRODE
Data sourced from openFDA. This site is unofficial and independent of the FDA.