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FDA 510(k)

BURDICK 200 PULSE OXIMETER

K-Number: K954267 · 1996-05-03

ApplicantBurdick, Inc.
Decision Date1996-05-03
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BURDICK 200 PULSE OXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Burdick, Inc.. It received FDA 510(k) clearance on 1996-05-03 under 510(k) number K954267. 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 BURDICK 200 PULSE OXIMETER?

BURDICK 200 PULSE OXIMETER is a medical device that received FDA 510(k) clearance on 1996-05-03. The listed applicant is Burdick, Inc.. The 510(k) number is K954267.

When did BURDICK 200 PULSE OXIMETER receive FDA 510(k) clearance?

BURDICK 200 PULSE OXIMETER received FDA 510(k) clearance on 1996-05-03, under 510(k) number K954267.

Who is the listed applicant for BURDICK 200 PULSE OXIMETER?

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

What is the FDA product code for BURDICK 200 PULSE OXIMETER?

The FDA product code for BURDICK 200 PULSE OXIMETER is DQA.

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Other records listing Burdick, 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.

K952417QUEST EXERCISE STRESS SYSTEMK946281ECLIPSE 4 ELECTROCARDIOGRAPHK945985PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400K943959ECLIPSE 4 ELECTROCARDIOGRAPHK942438ALTAIR 6100 CASSETTE RECORDER

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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