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FDA 510(k)

ADVISOR, MODEL 9200

K-Number: K030407 · 2003-08-19

ApplicantBci, Inc.
Decision Date2003-08-19
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ADVISOR, MODEL 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 2003-08-19 under 510(k) number K030407. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVISOR, MODEL 9200?

ADVISOR, MODEL 9200 is a medical device that received FDA 510(k) clearance on 2003-08-19. The listed applicant is Bci, Inc.. The 510(k) number is K030407.

When did ADVISOR, MODEL 9200 receive FDA 510(k) clearance?

ADVISOR, MODEL 9200 received FDA 510(k) clearance on 2003-08-19, under 510(k) number K030407.

Who is the listed applicant for ADVISOR, MODEL 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 ADVISOR, MODEL 9200?

The FDA product code for ADVISOR, MODEL 9200 is CCK.

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Other records listing Bci, Inc. as applicant

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K031742BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETERK020739BCI 3178 PEDIATRIC PULSE OXIMETRY SENSORK020350BCI 3180 PULSE OXIMETERK013862BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAMK0131713420 DIGIT PULSE OXIMETER, MODEL 3420K011156BCI 3403 SLEEP SCREENING PULSE OXIMETER

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Related Devices (Code: CCK)

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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