FDA 510(k)

MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE

K-Number: K022677 · 2002-09-11

Decision Date2002-09-11

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE 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 2002-09-11 under 510(k) number K022677. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE?

MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE is a medical device that received FDA 510(k) clearance on 2002-09-11. The listed applicant is Alaris Medical Systems, Inc.. The 510(k) number is K022677.

When did MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE receive FDA 510(k) clearance?

MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE received FDA 510(k) clearance on 2002-09-11, under 510(k) number K022677.

Who is the listed applicant for MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE?

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 MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE?

The FDA product code for MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE is DQA.

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Related Devices (Code: DQA)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.