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FDA 510(k)

MONARK 869 ERGOMETER

K-Number: K855102 · 1986-05-09

ApplicantEquilibrated Bio Systems, Inc.
Decision Date1986-05-09
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MONARK 869 ERGOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Equilibrated Bio Systems, Inc.. It received FDA 510(k) clearance on 1986-05-09 under 510(k) number K855102. The device is classified under product code DSP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONARK 869 ERGOMETER?

MONARK 869 ERGOMETER is a medical device that received FDA 510(k) clearance on 1986-05-09. The listed applicant is Equilibrated Bio Systems, Inc.. The 510(k) number is K855102.

When did MONARK 869 ERGOMETER receive FDA 510(k) clearance?

MONARK 869 ERGOMETER received FDA 510(k) clearance on 1986-05-09, under 510(k) number K855102.

Who is the listed applicant for MONARK 869 ERGOMETER?

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

What is the FDA product code for MONARK 869 ERGOMETER?

The FDA product code for MONARK 869 ERGOMETER is DSP.

Related Clinical Trials

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Other records listing Equilibrated Bio Systems, Inc. as applicant

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Related Devices (Code: DSP)

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.

K250542AC3™ Range™ Intra-Aortic Balloon PumpArrow International, LLCK232343AC3™ Series IABPArrow International, LLCK201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc.K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitArrow International, Inc.K192238AC3 Series Intra-Aortic Balloon Pump (IABP)Arrow International, TeleflexK190101UltraFlex IABArrow International, Inc.

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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