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FDA 510(k)

NK DEXTERITLY BOARD, MODEL BX001

K-Number: K914062 · 1991-12-09

ApplicantNk Biotechnical Engineering Co.
Decision Date1991-12-09
Product CodeKQX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NK DEXTERITLY BOARD, MODEL BX001 is the device name listed in this FDA 510(k) record. The listed applicant is Nk Biotechnical Engineering Co.. It received FDA 510(k) clearance on 1991-12-09 under 510(k) number K914062. The device is classified under product code KQX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NK DEXTERITLY BOARD, MODEL BX001?

NK DEXTERITLY BOARD, MODEL BX001 is a medical device that received FDA 510(k) clearance on 1991-12-09. The listed applicant is Nk Biotechnical Engineering Co.. The 510(k) number is K914062.

When did NK DEXTERITLY BOARD, MODEL BX001 receive FDA 510(k) clearance?

NK DEXTERITLY BOARD, MODEL BX001 received FDA 510(k) clearance on 1991-12-09, under 510(k) number K914062.

Who is the listed applicant for NK DEXTERITLY BOARD, MODEL BX001?

The FDA 510(k) record lists Nk Biotechnical Engineering Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NK DEXTERITLY BOARD, MODEL BX001?

The FDA product code for NK DEXTERITLY BOARD, MODEL BX001 is KQX.

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Other records listing Nk Biotechnical Engineering Co. 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.

K934368NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001K923965NK GRASP SENSOR, MODEL GA002K923964NK GRASP SENSOR, MODEL GA001K923963NK DIGI-GRIP SENSOR, MODEL DGR001K921268NK DYNA-GRIP SENSOR, MODEL DG001K921266NK MEDICAL MICROMETER, MODEL MC001

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Related Devices (Code: KQX)

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.

K011827ORTELIUS 800Orthoscan , Ltd.K971079INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWAREInterlogics, Inc.K9623773D-SPINESkill Technologies, Inc.K961212SPINAL TOUCHFasstechK954647INCLINOMETERJ-Tech, Inc.K943929DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS)Greenleaf Medical Systems, Inc.

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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