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FDA 510(k)

ZOOM-100DC

K-Number: K082886 · 2009-08-10

ApplicantBrainscope Company, Inc.
Decision Date2009-08-10
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ZOOM-100DC is the device name listed in this FDA 510(k) record. The listed applicant is Brainscope Company, Inc.. It received FDA 510(k) clearance on 2009-08-10 under 510(k) number K082886. 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 ZOOM-100DC?

ZOOM-100DC is a medical device that received FDA 510(k) clearance on 2009-08-10. The listed applicant is Brainscope Company, Inc.. The 510(k) number is K082886.

When did ZOOM-100DC receive FDA 510(k) clearance?

ZOOM-100DC received FDA 510(k) clearance on 2009-08-10, under 510(k) number K082886.

Who is the listed applicant for ZOOM-100DC?

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

What is the FDA product code for ZOOM-100DC?

The FDA product code for ZOOM-100DC is OLT.

Other records listing Brainscope Company, 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.

K190815BrainScope TBIK183241BrainScope TBI (Model: Ahead 400)K181785Modified BrainScope OneK181179BrainScope OneK161068Ahead 300

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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