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FDA 510(k)

PULMONARY FUNCTION SYS-3000

K-Number: K840711 · 1984-04-02

ApplicantMed-Science Electronics, Inc.
Decision Date1984-04-02
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PULMONARY FUNCTION SYS-3000 is the device name listed in this FDA 510(k) record. The listed applicant is Med-Science Electronics, Inc.. It received FDA 510(k) clearance on 1984-04-02 under 510(k) number K840711. 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 PULMONARY FUNCTION SYS-3000?

PULMONARY FUNCTION SYS-3000 is a medical device that received FDA 510(k) clearance on 1984-04-02. The listed applicant is Med-Science Electronics, Inc.. The 510(k) number is K840711.

When did PULMONARY FUNCTION SYS-3000 receive FDA 510(k) clearance?

PULMONARY FUNCTION SYS-3000 received FDA 510(k) clearance on 1984-04-02, under 510(k) number K840711.

Who is the listed applicant for PULMONARY FUNCTION SYS-3000?

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

What is the FDA product code for PULMONARY FUNCTION SYS-3000?

The FDA product code for PULMONARY FUNCTION SYS-3000 is BZC.

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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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