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FDA 510(k)

THE ELITE SPECTRUM

K-Number: K943396 · 1994-09-16

ApplicantInstantron
Decision Date1994-09-16
Product CodeKCW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

THE ELITE SPECTRUM is the device name listed in this FDA 510(k) record. The listed applicant is Instantron. It received FDA 510(k) clearance on 1994-09-16 under 510(k) number K943396. The device is classified under product code KCW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE ELITE SPECTRUM?

THE ELITE SPECTRUM is a medical device that received FDA 510(k) clearance on 1994-09-16. The listed applicant is Instantron. The 510(k) number is K943396.

When did THE ELITE SPECTRUM receive FDA 510(k) clearance?

THE ELITE SPECTRUM received FDA 510(k) clearance on 1994-09-16, under 510(k) number K943396.

Who is the listed applicant for THE ELITE SPECTRUM?

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

What is the FDA product code for THE ELITE SPECTRUM?

The FDA product code for THE ELITE SPECTRUM is KCW.

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Other records listing Instantron 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.

K943398THE BLENDTONE ROYALEK943399THE SS-99K941227SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVALK931063THE ELITE EPILATORK931062THE VP500 EPILATORK931064THE BLENDTONE EPILATOR

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Related Devices (Code: KCW)

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.

K954031COMPU-BLEND EPILATORR. A. Fischer Co. Corp.K952611STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATIONSterex Electrolysis Intl., Ltd.K945192HAIR REMOVAL SYSTEML.P. Systems Corp.K943928APILUS ELECTROPILDectro Intl., Inc.K943398THE BLENDTONE ROYALEInstantronK943399THE SS-99Instantron

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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