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FDA 510(k)

BCI ADVISOR VITAL SIGNS MONITOR (9200)

K-Number: K010770 · 2001-06-12

ApplicantBci, Inc.
Decision Date2001-06-12
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BCI ADVISOR VITAL SIGNS MONITOR (9200) is the device name listed in this FDA 510(k) record. The listed applicant is Bci, Inc.. It received FDA 510(k) clearance on 2001-06-12 under 510(k) number K010770. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BCI ADVISOR VITAL SIGNS MONITOR (9200)?

BCI ADVISOR VITAL SIGNS MONITOR (9200) is a medical device that received FDA 510(k) clearance on 2001-06-12. The listed applicant is Bci, Inc.. The 510(k) number is K010770.

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

BCI ADVISOR VITAL SIGNS MONITOR (9200) received FDA 510(k) clearance on 2001-06-12, under 510(k) number K010770.

Who is the listed applicant for BCI ADVISOR VITAL SIGNS MONITOR (9200)?

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

What is the FDA product code for BCI ADVISOR VITAL SIGNS MONITOR (9200)?

The FDA product code for BCI ADVISOR VITAL SIGNS MONITOR (9200) is MWI.

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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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Other records listing Bci, 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.

K030407ADVISOR, MODEL 9200K031742BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETERK020739BCI 3178 PEDIATRIC PULSE OXIMETRY SENSORK020350BCI 3180 PULSE OXIMETERK013862BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAMK0131713420 DIGIT PULSE OXIMETER, MODEL 3420

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Related Devices (Code: MWI)

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.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

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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