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FDA 510(k)

HUMAC SYSTEM

K-Number: K952090 · 1995-12-11

ApplicantComputer Sports Medicine, Inc.
Decision Date1995-12-11
Product CodeIKK
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HUMAC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Computer Sports Medicine, Inc.. It received FDA 510(k) clearance on 1995-12-11 under 510(k) number K952090. The device is classified under product code IKK. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMAC SYSTEM?

HUMAC SYSTEM is a medical device that received FDA 510(k) clearance on 1995-12-11. The listed applicant is Computer Sports Medicine, Inc.. The 510(k) number is K952090.

When did HUMAC SYSTEM receive FDA 510(k) clearance?

HUMAC SYSTEM received FDA 510(k) clearance on 1995-12-11, under 510(k) number K952090.

Who is the listed applicant for HUMAC SYSTEM?

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

What is the FDA product code for HUMAC SYSTEM?

The FDA product code for HUMAC SYSTEM is IKK.

Related Clinical Trials

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Related Devices (Code: IKK)

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.

K123746AMES THERAPY DEVICEAmes Technology, Inc.K951770BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3APBiodex Medical Systems, Inc.K951916CC RIDER, MODEL ME180Mettler Electronics Corp.K950095CYBEX 770CybexK942229MOTIVATOR FTR 2000Hogan & HartsonK944732DEXTER ISOKINETICCedaron Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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