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FDA 510(k)

EXERSYSTEM(TM) MMC 5000

K-Number: K864911 · 1987-08-21

ApplicantMed Science
Decision Date1987-08-21
Product CodeBZM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EXERSYSTEM(TM) MMC 5000 is the device name listed in this FDA 510(k) record. The listed applicant is Med Science. It received FDA 510(k) clearance on 1987-08-21 under 510(k) number K864911. 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 EXERSYSTEM(TM) MMC 5000?

EXERSYSTEM(TM) MMC 5000 is a medical device that received FDA 510(k) clearance on 1987-08-21. The listed applicant is Med Science. The 510(k) number is K864911.

When did EXERSYSTEM(TM) MMC 5000 receive FDA 510(k) clearance?

EXERSYSTEM(TM) MMC 5000 received FDA 510(k) clearance on 1987-08-21, under 510(k) number K864911.

Who is the listed applicant for EXERSYSTEM(TM) MMC 5000?

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

What is the FDA product code for EXERSYSTEM(TM) MMC 5000?

The FDA product code for EXERSYSTEM(TM) MMC 5000 is BZM.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Med Science 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.

K921306ARGIS PULMONARY FUNCTION TESTING SYSTEM

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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