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FDA 510(k)

BIOCHEM 6100 NON-INVASIVE MONITOR

K-Number: K903222 · 1990-09-04

ApplicantBiochem International, Inc.
Decision Date1990-09-04
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOCHEM 6100 NON-INVASIVE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Biochem International, Inc.. It received FDA 510(k) clearance on 1990-09-04 under 510(k) number K903222. 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 BIOCHEM 6100 NON-INVASIVE MONITOR?

BIOCHEM 6100 NON-INVASIVE MONITOR is a medical device that received FDA 510(k) clearance on 1990-09-04. The listed applicant is Biochem International, Inc.. The 510(k) number is K903222.

When did BIOCHEM 6100 NON-INVASIVE MONITOR receive FDA 510(k) clearance?

BIOCHEM 6100 NON-INVASIVE MONITOR received FDA 510(k) clearance on 1990-09-04, under 510(k) number K903222.

Who is the listed applicant for BIOCHEM 6100 NON-INVASIVE MONITOR?

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

What is the FDA product code for BIOCHEM 6100 NON-INVASIVE MONITOR?

The FDA product code for BIOCHEM 6100 NON-INVASIVE MONITOR is DXN.

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Other records listing Biochem International, 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.

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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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