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FDA 510(k)

REUSABLE FINGER SENSOR 3444

K-Number: K974697 · 1998-03-11

ApplicantBci Intl., Inc.
Decision Date1998-03-11
Product CodeDQH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REUSABLE FINGER SENSOR 3444 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 1998-03-11 under 510(k) number K974697. The device is classified under product code DQH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REUSABLE FINGER SENSOR 3444?

REUSABLE FINGER SENSOR 3444 is a medical device that received FDA 510(k) clearance on 1998-03-11. The listed applicant is Bci Intl., Inc.. The 510(k) number is K974697.

When did REUSABLE FINGER SENSOR 3444 receive FDA 510(k) clearance?

REUSABLE FINGER SENSOR 3444 received FDA 510(k) clearance on 1998-03-11, under 510(k) number K974697.

Who is the listed applicant for REUSABLE FINGER SENSOR 3444?

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 REUSABLE FINGER SENSOR 3444?

The FDA product code for REUSABLE FINGER SENSOR 3444 is DQH.

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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.

K9914103402 HANDHELD PULSE OXIMETERK991086CAPNOCHECK II, MODEL 8400K984618BCI MINI-TORR PLUS, MODEL 6004K9837966004 NIBP MONITOR WITH TEMPERATUREK982279VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200K981939AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR

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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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