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FDA 510(k)

METRON QA-510 SPO2 ANALYZER

K-Number: K973991 · 1998-01-16

ApplicantMetron U.S., Inc.
Decision Date1998-01-16
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

METRON QA-510 SPO2 ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Metron U.S., Inc.. It received FDA 510(k) clearance on 1998-01-16 under 510(k) number K973991. 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 METRON QA-510 SPO2 ANALYZER?

METRON QA-510 SPO2 ANALYZER is a medical device that received FDA 510(k) clearance on 1998-01-16. The listed applicant is Metron U.S., Inc.. The 510(k) number is K973991.

When did METRON QA-510 SPO2 ANALYZER receive FDA 510(k) clearance?

METRON QA-510 SPO2 ANALYZER received FDA 510(k) clearance on 1998-01-16, under 510(k) number K973991.

Who is the listed applicant for METRON QA-510 SPO2 ANALYZER?

The FDA 510(k) record lists Metron U.S., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for METRON QA-510 SPO2 ANALYZER?

The FDA product code for METRON QA-510 SPO2 ANALYZER is DQA.

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Other records listing Metron U.S., Inc. 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.

K982020METRON QA-IDS I.V. PUMP TESTERK963190QA-40M DEFIBRILLATOR TESTERK963198PS-41 6M PATIENT SIMULATOR

Related Devices (Code: DQA)

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.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

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.

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