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FDA 510(k)

BIO-COORDINATOR SYSTEM

K-Number: K895398 · 1989-09-28

ApplicantBio-Harmonizer, Inc.
Decision Date1989-09-28
Product CodeIKK
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BIO-COORDINATOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Harmonizer, Inc.. It received FDA 510(k) clearance on 1989-09-28 under 510(k) number K895398. 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 BIO-COORDINATOR SYSTEM?

BIO-COORDINATOR SYSTEM is a medical device that received FDA 510(k) clearance on 1989-09-28. The listed applicant is Bio-Harmonizer, Inc.. The 510(k) number is K895398.

When did BIO-COORDINATOR SYSTEM receive FDA 510(k) clearance?

BIO-COORDINATOR SYSTEM received FDA 510(k) clearance on 1989-09-28, under 510(k) number K895398.

Who is the listed applicant for BIO-COORDINATOR SYSTEM?

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

What is the FDA product code for BIO-COORDINATOR SYSTEM?

The FDA product code for BIO-COORDINATOR SYSTEM is IKK.

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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

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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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