EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED)— 510(k) K010085

Name: FDA 510(k) clearance K010085
Creator: U.S. Food and Drug Administration
Published: 2001-03-15

Substantially Equivalent

Excel Tech. , Ltd.

FDA 510(k) clearance K010085 for EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED), Substantially Equivalent on 2001-03-15. Applicant: Excel Tech. , Ltd.. Device class: 2.

Clearance details

Applicant: Excel Tech. , Ltd.
Product code: Code OMB
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2001-01-11
Decision date: 2001-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakville, CA

Download summary PDF View on FDA.gov ↗

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