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FDA 510(k)

BIOCHEM MODEL 3302 NEWOX2 OXIMETER

K-Number: K920083 · 1994-04-11

ApplicantBiochem International, Inc.
Decision Date1994-04-11
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOCHEM MODEL 3302 NEWOX2 OXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Biochem International, Inc.. It received FDA 510(k) clearance on 1994-04-11 under 510(k) number K920083. 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 BIOCHEM MODEL 3302 NEWOX2 OXIMETER?

BIOCHEM MODEL 3302 NEWOX2 OXIMETER is a medical device that received FDA 510(k) clearance on 1994-04-11. The listed applicant is Biochem International, Inc.. The 510(k) number is K920083.

When did BIOCHEM MODEL 3302 NEWOX2 OXIMETER receive FDA 510(k) clearance?

BIOCHEM MODEL 3302 NEWOX2 OXIMETER received FDA 510(k) clearance on 1994-04-11, under 510(k) number K920083.

Who is the listed applicant for BIOCHEM MODEL 3302 NEWOX2 OXIMETER?

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

What is the FDA product code for BIOCHEM MODEL 3302 NEWOX2 OXIMETER?

The FDA product code for BIOCHEM MODEL 3302 NEWOX2 OXIMETER is DQA.

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Other records listing Biochem International, 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.

K9323898100 ANESTHETIC AGENT MONITORK921388BIOCHEM 9100 MULTIGAS MONITOR IBP MODULEK920082BIOCHEM MODEL 3301 NEWOX1 OXIMETERK911351BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBPK910381BIOCHEM TEMPERATURE/ FIO2 MODULEK903222BIOCHEM 6100 NON-INVASIVE MONITOR

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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

View on FDA Database →

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

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