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FDA 510(k)

VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200

K-Number: K982279 · 1998-09-25

ApplicantBci Intl., Inc.
Decision Date1998-09-25
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 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 1998-09-25 under 510(k) number K982279. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200?

VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 is a medical device that received FDA 510(k) clearance on 1998-09-25. The listed applicant is Bci Intl., Inc.. The 510(k) number is K982279.

When did VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 receive FDA 510(k) clearance?

VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 received FDA 510(k) clearance on 1998-09-25, under 510(k) number K982279.

Who is the listed applicant for VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200?

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 VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200?

The FDA product code for VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 is MHX.

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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 TEMPERATUREK981939AUTOCORR PLUS; 3404 OXIMETER/ECG MONITORK980714BCI 3401 HANDHELD PULSE OXIMETER

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Related Devices (Code: MHX)

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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