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FDA 510(k)

BIOX III

K-Number: K820110 · 1982-02-12

ApplicantBiox Technology, Inc.
Decision Date1982-02-12
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOX III is the device name listed in this FDA 510(k) record. The listed applicant is Biox Technology, Inc.. It received FDA 510(k) clearance on 1982-02-12 under 510(k) number K820110. 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 BIOX III?

BIOX III is a medical device that received FDA 510(k) clearance on 1982-02-12. The listed applicant is Biox Technology, Inc.. The 510(k) number is K820110.

When did BIOX III receive FDA 510(k) clearance?

BIOX III received FDA 510(k) clearance on 1982-02-12, under 510(k) number K820110.

Who is the listed applicant for BIOX III?

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

What is the FDA product code for BIOX III?

The FDA product code for BIOX III is DQA.

Other records listing Biox Technology, 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.

K833826BTI BIOX III OXIMETER CRITICAL CAREUNI

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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