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FDA 510(k)

RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR

K-Number: K853848 · 1985-12-05

ApplicantMedical Graphics Corp.
Decision Date1985-12-05
Product CodeBXW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR 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 1985-12-05 under 510(k) number K853848. The device is classified under product code BXW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR?

RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR is a medical device that received FDA 510(k) clearance on 1985-12-05. The listed applicant is Medical Graphics Corp.. The 510(k) number is K853848.

When did RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR receive FDA 510(k) clearance?

RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR received FDA 510(k) clearance on 1985-12-05, under 510(k) number K853848.

Who is the listed applicant for RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR?

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 RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR?

The FDA product code for RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR is BXW.

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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: BXW)

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.

K831758FLOW-CALIBRATION MODULEThe Perkin-Elmer Corp.K830898SYRINGE 500BC BE #7000Instrumentation Industries, Inc.K812765DATASCRIBE #DS-40Timeter Instrument Corp.K810290OHIO CAL-CHEKOhio Medical ProductsK760520CALIPERS, MCGAW SKINFOLDMcgaw Laboratories

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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