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FDA 510(k)

BTI BIOX III OXIMETER CRITICAL CAREUNI

K-Number: K833826 · 1983-12-30

ApplicantBiox Technology, Inc.
Decision Date1983-12-30
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BTI BIOX III OXIMETER CRITICAL CAREUNI 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 1983-12-30 under 510(k) number K833826. 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 BTI BIOX III OXIMETER CRITICAL CAREUNI?

BTI BIOX III OXIMETER CRITICAL CAREUNI is a medical device that received FDA 510(k) clearance on 1983-12-30. The listed applicant is Biox Technology, Inc.. The 510(k) number is K833826.

When did BTI BIOX III OXIMETER CRITICAL CAREUNI receive FDA 510(k) clearance?

BTI BIOX III OXIMETER CRITICAL CAREUNI received FDA 510(k) clearance on 1983-12-30, under 510(k) number K833826.

Who is the listed applicant for BTI BIOX III OXIMETER CRITICAL CAREUNI?

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 BTI BIOX III OXIMETER CRITICAL CAREUNI?

The FDA product code for BTI BIOX III OXIMETER CRITICAL CAREUNI is DQA.

Related Clinical Trials

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.

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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.

K820110BIOX III

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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