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FDA 510(k)

OXI TEMP

K-Number: K963496 · 1996-11-26

ApplicantBci Intl., Inc.
Decision Date1996-11-26
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OXI TEMP 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 1996-11-26 under 510(k) number K963496. 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 OXI TEMP?

OXI TEMP is a medical device that received FDA 510(k) clearance on 1996-11-26. The listed applicant is Bci Intl., Inc.. The 510(k) number is K963496.

When did OXI TEMP receive FDA 510(k) clearance?

OXI TEMP received FDA 510(k) clearance on 1996-11-26, under 510(k) number K963496.

Who is the listed applicant for OXI TEMP?

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 OXI TEMP?

The FDA product code for OXI TEMP is DQA.

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.

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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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