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FDA 510(k)

BIS CLICK SENSOR/CABLE

K-Number: K091854 · 2009-07-02

ApplicantAspect Medical Systems, Inc.
Decision Date2009-07-02
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIS CLICK SENSOR/CABLE is the device name listed in this FDA 510(k) record. The listed applicant is Aspect Medical Systems, Inc.. It received FDA 510(k) clearance on 2009-07-02 under 510(k) number K091854. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIS CLICK SENSOR/CABLE?

BIS CLICK SENSOR/CABLE is a medical device that received FDA 510(k) clearance on 2009-07-02. The listed applicant is Aspect Medical Systems, Inc.. The 510(k) number is K091854.

When did BIS CLICK SENSOR/CABLE receive FDA 510(k) clearance?

BIS CLICK SENSOR/CABLE received FDA 510(k) clearance on 2009-07-02, under 510(k) number K091854.

Who is the listed applicant for BIS CLICK SENSOR/CABLE?

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

What is the FDA product code for BIS CLICK SENSOR/CABLE?

The FDA product code for BIS CLICK SENSOR/CABLE is GXY.

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Other records listing Aspect Medical Systems, Inc. as applicant

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Related Devices (Code: GXY)

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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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