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FDA 510(k)

A-LINE AEP MONITOR

K-Number: K010965 · 2001-06-27

ApplicantAlaris Medical Systems, Inc.
Decision Date2001-06-27
Product CodeOLW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

A-LINE AEP MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Alaris Medical Systems, Inc.. It received FDA 510(k) clearance on 2001-06-27 under 510(k) number K010965. The device is classified under product code OLW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A-LINE AEP MONITOR?

A-LINE AEP MONITOR is a medical device that received FDA 510(k) clearance on 2001-06-27. The listed applicant is Alaris Medical Systems, Inc.. The 510(k) number is K010965.

When did A-LINE AEP MONITOR receive FDA 510(k) clearance?

A-LINE AEP MONITOR received FDA 510(k) clearance on 2001-06-27, under 510(k) number K010965.

Who is the listed applicant for A-LINE AEP MONITOR?

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

What is the FDA product code for A-LINE AEP MONITOR?

The FDA product code for A-LINE AEP MONITOR is OLW.

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Other records listing Alaris Medical Systems, Inc. as applicant

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Related Devices (Code: OLW)

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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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