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FDA 510(k)

TOPOGRAPHIC BRAIN MAPPING OPTION

K-Number: K934050 · 1994-02-03

ApplicantBiosound, Inc.
Decision Date1994-02-03
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TOPOGRAPHIC BRAIN MAPPING OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Biosound, Inc.. It received FDA 510(k) clearance on 1994-02-03 under 510(k) number K934050. The device is classified under product code OLT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOPOGRAPHIC BRAIN MAPPING OPTION?

TOPOGRAPHIC BRAIN MAPPING OPTION is a medical device that received FDA 510(k) clearance on 1994-02-03. The listed applicant is Biosound, Inc.. The 510(k) number is K934050.

When did TOPOGRAPHIC BRAIN MAPPING OPTION receive FDA 510(k) clearance?

TOPOGRAPHIC BRAIN MAPPING OPTION received FDA 510(k) clearance on 1994-02-03, under 510(k) number K934050.

Who is the listed applicant for TOPOGRAPHIC BRAIN MAPPING OPTION?

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

What is the FDA product code for TOPOGRAPHIC BRAIN MAPPING OPTION?

The FDA product code for TOPOGRAPHIC BRAIN MAPPING OPTION is OLT.

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Other records listing Biosound, Inc. 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.

K971700BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCERK963936ACCESSPOINT, MED E-MAIL, DICOM READERK963262ARTOSCAN MK963662GALILEO EVOKED POTENTIALREK953716INTRACAVITY TRANSDUCERSK953530DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A

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Related Devices (Code: OLT)

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.

K261712Ceribell EEG Analysis SoftwareCeribell, Inc.K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc.K253767UB ERP SystemUniversal BrainK251881HippoMind (v1.0)HippoclinicK251366EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)Nihon Kohden CorporationK240593VEEGix EEG SystemNeuroServo, Inc.

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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