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FDA 510(k)

OXITEMP, 3301T SA

K-Number: K960058 · 1996-05-15

ApplicantBci Intl., Inc.
Decision Date1996-05-15
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OXITEMP, 3301T SA is the device name listed in this FDA 510(k) record. The listed applicant is Bci Intl., Inc.. It received FDA 510(k) clearance on 1996-05-15 under 510(k) number K960058. 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 OXITEMP, 3301T SA?

OXITEMP, 3301T SA is a medical device that received FDA 510(k) clearance on 1996-05-15. The listed applicant is Bci Intl., Inc.. The 510(k) number is K960058.

When did OXITEMP, 3301T SA receive FDA 510(k) clearance?

OXITEMP, 3301T SA received FDA 510(k) clearance on 1996-05-15, under 510(k) number K960058.

Who is the listed applicant for OXITEMP, 3301T SA?

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

What is the FDA product code for OXITEMP, 3301T SA?

The FDA product code for OXITEMP, 3301T SA is DQA.

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Other records listing Bci Intl., 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.

K991086CAPNOCHECK II, MODEL 8400K9914103402 HANDHELD PULSE OXIMETERK984618BCI MINI-TORR PLUS, MODEL 6004K9837966004 NIBP MONITOR WITH TEMPERATUREK982279VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200K981939AUTOCORR PLUS; 3404 OXIMETER/ECG 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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