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FDA 510(k)

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

K-Number: K010085 · 2001-03-15

ApplicantExcel Tech. , Ltd.
Decision Date2001-03-15
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED) is the device name listed in this FDA 510(k) record. The listed applicant is Excel Tech. , Ltd.. It received FDA 510(k) clearance on 2001-03-15 under 510(k) number K010085. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED)?

EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED) is a medical device that received FDA 510(k) clearance on 2001-03-15. The listed applicant is Excel Tech. , Ltd.. The 510(k) number is K010085.

When did EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED) receive FDA 510(k) clearance?

EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED) received FDA 510(k) clearance on 2001-03-15, under 510(k) number K010085.

Who is the listed applicant for EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED)?

The FDA 510(k) record lists Excel Tech. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED)?

The FDA product code for EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED) is OMB.

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Other records listing Excel Tech. , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K062549XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238K061269XLTEK CLEAN SIGNAL ADHESIVE ELECTRODESK053386XLTEK EMU40 EEG HEADBOX, MODEL PK1072K053058XLTEK NEUROPATH, MODEL PK1070K052112XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059K052111XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382

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Related Devices (Code: OMB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260998Ceribell Neurology Review SoftwareCeribell, Inc.K252070Ceribell Infant Seizure Detection SoftwareCeribell, Inc.K252160Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development, LLCK241589Ceribell Seizure Detection SoftwareCeribell, Inc.K243743autoSCORE (V 2.0.0)Holberg Eeg ASK242446Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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