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FDA 510(k)

LIFELINES PHOTIC STIMULATOR

K-Number: K101691 · 2010-08-10

ApplicantLifelines , Ltd.
Decision Date2010-08-10
Product CodeGWE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LIFELINES PHOTIC STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Lifelines , Ltd.. It received FDA 510(k) clearance on 2010-08-10 under 510(k) number K101691. The device is classified under product code GWE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFELINES PHOTIC STIMULATOR?

LIFELINES PHOTIC STIMULATOR is a medical device that received FDA 510(k) clearance on 2010-08-10. The listed applicant is Lifelines , Ltd.. The 510(k) number is K101691.

When did LIFELINES PHOTIC STIMULATOR receive FDA 510(k) clearance?

LIFELINES PHOTIC STIMULATOR received FDA 510(k) clearance on 2010-08-10, under 510(k) number K101691.

Who is the listed applicant for LIFELINES PHOTIC STIMULATOR?

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

What is the FDA product code for LIFELINES PHOTIC STIMULATOR?

The FDA product code for LIFELINES PHOTIC STIMULATOR is GWE.

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Other records listing Lifelines , 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.

K172271Trackit T4 EEG AmplifierK010460LIFELINES TRACKIT

Related Devices (Code: GWE)

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.

K221471E3 and ProfileDiagnosys, LLCK212936Vision Monitor- MonCvONEMetrovisionK211974LED PHOTIC SystemMicromed S.P.A.K211643Vision Monitor - MonpackONEMetrovisionK200705Nurochek SystemCryptych Pty, Ltd.K173936Natus Photic StimulatorNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

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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