REUSABLE DUAL DISC BAR RECORDING ELECTRODES— 510(k) K923665
Substantially EquivalentChalgren Enterprises, Inc.
FDA 510(k) clearance K923665 for REUSABLE DUAL DISC BAR RECORDING ELECTRODES, Substantially Equivalent on 1992-10-05. 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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- K960591 — RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP
- 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.