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FDA 510(k)

BIOCHEM 515 RESPIRATION MONITOR

K-Number: K854333 · 1986-05-30

ApplicantBiochem International, Inc.
Decision Date1986-05-30
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BIOCHEM 515 RESPIRATION 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 1986-05-30 under 510(k) number K854333. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCHEM 515 RESPIRATION MONITOR?

BIOCHEM 515 RESPIRATION MONITOR is a medical device that received FDA 510(k) clearance on 1986-05-30. The listed applicant is Biochem International, Inc.. The 510(k) number is K854333.

When did BIOCHEM 515 RESPIRATION MONITOR receive FDA 510(k) clearance?

BIOCHEM 515 RESPIRATION MONITOR received FDA 510(k) clearance on 1986-05-30, under 510(k) number K854333.

Who is the listed applicant for BIOCHEM 515 RESPIRATION 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 515 RESPIRATION MONITOR?

The FDA product code for BIOCHEM 515 RESPIRATION MONITOR is BZQ.

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Other records listing Biochem International, Inc. as applicant

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Related Devices (Code: BZQ)

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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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