FDA 510(k)

TEST ONE

K-Number: K894662 · 1989-12-13

Decision Date1989-12-13

Product CodeIKK

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

TEST ONE is the device name listed in this FDA 510(k) record. The listed applicant is Primed Products, Inc.. It received FDA 510(k) clearance on 1989-12-13 under 510(k) number K894662. 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 TEST ONE?

TEST ONE is a medical device that received FDA 510(k) clearance on 1989-12-13. The listed applicant is Primed Products, Inc.. The 510(k) number is K894662.

When did TEST ONE receive FDA 510(k) clearance?

TEST ONE received FDA 510(k) clearance on 1989-12-13, under 510(k) number K894662.

Who is the listed applicant for TEST ONE?

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

What is the FDA product code for TEST ONE?

The FDA product code for TEST ONE is IKK.

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 770Cybex K942229MOTIVATOR 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.