Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NICOLET VIKING II SYSTEM

K-Number: K890495 · 1989-03-16

ApplicantNicolet Instrument Corp.
Decision Date1989-03-16
Product CodeIKN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

NICOLET VIKING II SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nicolet Instrument Corp.. It received FDA 510(k) clearance on 1989-03-16 under 510(k) number K890495. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NICOLET VIKING II SYSTEM?

NICOLET VIKING II SYSTEM is a medical device that received FDA 510(k) clearance on 1989-03-16. The listed applicant is Nicolet Instrument Corp.. The 510(k) number is K890495.

When did NICOLET VIKING II SYSTEM receive FDA 510(k) clearance?

NICOLET VIKING II SYSTEM received FDA 510(k) clearance on 1989-03-16, under 510(k) number K890495.

Who is the listed applicant for NICOLET VIKING II SYSTEM?

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

What is the FDA product code for NICOLET VIKING II SYSTEM?

The FDA product code for NICOLET VIKING II SYSTEM is IKN.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Nicolet Instrument 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.

K921138NICOLET ULTRASOM ACQUISITION STATIONK923315NICOLET ARK SYSTEMK921927NICOLET VOYAGEURK915652NICOLET PORATBLE SPIRIT SYSTEMK905632NICOLET MAPLELEAF SYSTEMK897154NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE

View all 13 devices →

Related Devices (Code: IKN)

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.

K172743Natus VikingQuestNatus Neurology IncorporatedK163150ViMove2Dorsavi, Ltd.K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc.K123902PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)Oktx, LLCK123399MYOVISION 3.0 WIREFREE SYSTEMPrecision Biometrics, Inc.K113074CMAP PROMedical Technologies, 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.

↑