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FDA 510(k)

BCI MINI-TORR PLUS, MODEL 6004

K-Number: K984618 · 1999-03-25

ApplicantBci Intl., Inc.
Decision Date1999-03-25
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BCI MINI-TORR PLUS, MODEL 6004 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 1999-03-25 under 510(k) number K984618. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BCI MINI-TORR PLUS, MODEL 6004?

BCI MINI-TORR PLUS, MODEL 6004 is a medical device that received FDA 510(k) clearance on 1999-03-25. The listed applicant is Bci Intl., Inc.. The 510(k) number is K984618.

When did BCI MINI-TORR PLUS, MODEL 6004 receive FDA 510(k) clearance?

BCI MINI-TORR PLUS, MODEL 6004 received FDA 510(k) clearance on 1999-03-25, under 510(k) number K984618.

Who is the listed applicant for BCI MINI-TORR PLUS, MODEL 6004?

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 BCI MINI-TORR PLUS, MODEL 6004?

The FDA product code for BCI MINI-TORR PLUS, MODEL 6004 is DXN.

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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 8400K9837966004 NIBP MONITOR WITH TEMPERATUREK982279VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200K981939AUTOCORR PLUS; 3404 OXIMETER/ECG MONITORK980714BCI 3401 HANDHELD PULSE OXIMETER

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Related Devices (Code: DXN)

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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