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FDA 510(k)

MFE CARDIAC STRESS SYSTEM

K-Number: K850868 · 1985-06-12

ApplicantKetronic, Inc.
Decision Date1985-06-12
Product Code
DecisionSubstantially Equivalent

Device Summary

MFE CARDIAC STRESS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ketronic, Inc.. It received FDA 510(k) clearance on 1985-06-12 under 510(k) number K850868. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MFE CARDIAC STRESS SYSTEM?

MFE CARDIAC STRESS SYSTEM is a medical device that received FDA 510(k) clearance on 1985-06-12. The listed applicant is Ketronic, Inc.. The 510(k) number is K850868.

When did MFE CARDIAC STRESS SYSTEM receive FDA 510(k) clearance?

MFE CARDIAC STRESS SYSTEM received FDA 510(k) clearance on 1985-06-12, under 510(k) number K850868.

Who is the listed applicant for MFE CARDIAC STRESS SYSTEM?

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

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Other records listing Ketronic, Inc. 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.

K850869MFE COUCH ERGOMETERK850873HILO TABLES, TYPE CH-4, CH-8, FW-6, FW-5, FW-2, ALK850877MONOLIFT MPE2, PLATFORM, CHAIR, FULLY FUTO PLATFORK850870MEDIFETTE ERGOMETERK850872PHYACTION 300, 360, 370, 390 & 391 ELEC-MUSCLE-STIK850871TREDBAND TYPE I, IT, II & III - TREADMILLS

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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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