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FDA 510(k)

PULMONARY LAB AUTOMATION SYSTEM

K-Number: K801496 · 1980-07-21

ApplicantMedical Graphics Corp.
Decision Date1980-07-21
Product CodeBZM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PULMONARY LAB AUTOMATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Graphics Corp.. It received FDA 510(k) clearance on 1980-07-21 under 510(k) number K801496. The device is classified under product code BZM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULMONARY LAB AUTOMATION SYSTEM?

PULMONARY LAB AUTOMATION SYSTEM is a medical device that received FDA 510(k) clearance on 1980-07-21. The listed applicant is Medical Graphics Corp.. The 510(k) number is K801496.

When did PULMONARY LAB AUTOMATION SYSTEM receive FDA 510(k) clearance?

PULMONARY LAB AUTOMATION SYSTEM received FDA 510(k) clearance on 1980-07-21, under 510(k) number K801496.

Who is the listed applicant for PULMONARY LAB AUTOMATION SYSTEM?

The FDA 510(k) record lists Medical Graphics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PULMONARY LAB AUTOMATION SYSTEM?

The FDA product code for PULMONARY LAB AUTOMATION SYSTEM is BZM.

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Other records listing Medical Graphics Corp. 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.

K152585Resmon PRO FULLK070858EXPRESS SERIESK061731MEDGRAPHICS ULTIMA SYSTEMK955432CPX, CCM, CATH WITH 15% CO2K9432591085 ULTIMATE E PLETHYSMOGRAPHK923209MEDGRAPHICS EXERCISE CONSULT

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Related Devices (Code: BZM)

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.

K102229PULMOTRACK 2020 SYSTEMKarmelsonixK090863PERSONAL WHEEZOMETERKarmelsonixK071955WIM-PC, MODEL 1010KarmelsonixK012387STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEMStethographics, Inc.K980878PULMOTRACK,MODEL 1010Karmel Medical Acoustic Technologies , Ltd.K974200ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEMOrca Diagnostics Corp.

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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