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FDA 510(k)

BIS QUATRO SENSOR

K-Number: K093183 · 2009-10-23

ApplicantAspect Medical Systems, Inc.
Decision Date2009-10-23
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIS QUATRO SENSOR 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 2009-10-23 under 510(k) number K093183. 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 QUATRO SENSOR?

BIS QUATRO SENSOR is a medical device that received FDA 510(k) clearance on 2009-10-23. The listed applicant is Aspect Medical Systems, Inc.. The 510(k) number is K093183.

When did BIS QUATRO SENSOR receive FDA 510(k) clearance?

BIS QUATRO SENSOR received FDA 510(k) clearance on 2009-10-23, under 510(k) number K093183.

Who is the listed applicant for BIS QUATRO SENSOR?

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 QUATRO SENSOR?

The FDA product code for BIS QUATRO SENSOR is 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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