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FDA 510(k)

SPIRO-LINK REAL TIME SPIROMETRY SYSTEM

K-Number: K892121 · 1989-06-16

ApplicantBiocom Intl., Inc.
Decision Date1989-06-16
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIRO-LINK REAL TIME SPIROMETRY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biocom Intl., Inc.. It received FDA 510(k) clearance on 1989-06-16 under 510(k) number K892121. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIRO-LINK REAL TIME SPIROMETRY SYSTEM?

SPIRO-LINK REAL TIME SPIROMETRY SYSTEM is a medical device that received FDA 510(k) clearance on 1989-06-16. The listed applicant is Biocom Intl., Inc.. The 510(k) number is K892121.

When did SPIRO-LINK REAL TIME SPIROMETRY SYSTEM receive FDA 510(k) clearance?

SPIRO-LINK REAL TIME SPIROMETRY SYSTEM received FDA 510(k) clearance on 1989-06-16, under 510(k) number K892121.

Who is the listed applicant for SPIRO-LINK REAL TIME SPIROMETRY SYSTEM?

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

What is the FDA product code for SPIRO-LINK REAL TIME SPIROMETRY SYSTEM?

The FDA product code for SPIRO-LINK REAL TIME SPIROMETRY SYSTEM is BZC.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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