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FDA 510(k)

BIODEX,MODEL B-2000

K-Number: K913021 · 1991-10-03

ApplicantBiodex Corp.
Decision Date1991-10-03
Product CodeIKK
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BIODEX,MODEL B-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Biodex Corp.. It received FDA 510(k) clearance on 1991-10-03 under 510(k) number K913021. 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 BIODEX,MODEL B-2000?

BIODEX,MODEL B-2000 is a medical device that received FDA 510(k) clearance on 1991-10-03. The listed applicant is Biodex Corp.. The 510(k) number is K913021.

When did BIODEX,MODEL B-2000 receive FDA 510(k) clearance?

BIODEX,MODEL B-2000 received FDA 510(k) clearance on 1991-10-03, under 510(k) number K913021.

Who is the listed applicant for BIODEX,MODEL B-2000?

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

What is the FDA product code for BIODEX,MODEL B-2000?

The FDA product code for BIODEX,MODEL B-2000 is IKK.

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Other records listing Biodex 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.

K915846BIODEX SYSTEM 2 AUTOPROGRAMK915648BIODEX SYSTEM 2 AUTOPROGRAMK913020BIODEX SYSTEM 2,MODEL S2-SK900450BIODEX LIFT SIMULATORK900741BIODEX BACK SYSTEM ATTACHMENTK860821BIODEX SYSTEM

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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.K952090HUMAC SYSTEMComputer Sports Medicine, Inc.K951770BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3APBiodex Medical Systems, Inc.K951916CC RIDER, MODEL ME180Mettler Electronics Corp.K950095CYBEX 770CybexK942229MOTIVATOR FTR 2000Hogan & Hartson

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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