FDA 510(k)

SPIROMETRICS 2451 & SMI I

K-Number: K844333 · 1984-11-20

Decision Date1984-11-20

Product CodeBZG

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

SPIROMETRICS 2451 & SMI I is the device name listed in this FDA 510(k) record. The listed applicant is Spirometrics, Inc.. It received FDA 510(k) clearance on 1984-11-20 under 510(k) number K844333. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIROMETRICS 2451 & SMI I?

SPIROMETRICS 2451 & SMI I is a medical device that received FDA 510(k) clearance on 1984-11-20. The listed applicant is Spirometrics, Inc.. The 510(k) number is K844333.

When did SPIROMETRICS 2451 & SMI I receive FDA 510(k) clearance?

SPIROMETRICS 2451 & SMI I received FDA 510(k) clearance on 1984-11-20, under 510(k) number K844333.

Who is the listed applicant for SPIROMETRICS 2451 & SMI I?

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

What is the FDA product code for SPIROMETRICS 2451 & SMI I?

The FDA product code for SPIROMETRICS 2451 & SMI I is BZG.

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Other records listing Spirometrics, Inc. as applicant

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Related Devices (Code: BZG)

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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.