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FDA 510(k)

BIOCHEM 8090 CAPNOGRAPH

K-Number: K871133 · 1987-04-21

ApplicantBiochem International, Inc.
Decision Date1987-04-21
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BIOCHEM 8090 CAPNOGRAPH 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 1987-04-21 under 510(k) number K871133. 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 BIOCHEM 8090 CAPNOGRAPH?

BIOCHEM 8090 CAPNOGRAPH is a medical device that received FDA 510(k) clearance on 1987-04-21. The listed applicant is Biochem International, Inc.. The 510(k) number is K871133.

When did BIOCHEM 8090 CAPNOGRAPH receive FDA 510(k) clearance?

BIOCHEM 8090 CAPNOGRAPH received FDA 510(k) clearance on 1987-04-21, under 510(k) number K871133.

Who is the listed applicant for BIOCHEM 8090 CAPNOGRAPH?

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 8090 CAPNOGRAPH?

The FDA product code for BIOCHEM 8090 CAPNOGRAPH is CCK.

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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: 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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