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FDA 510(k)

SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646

K-Number: K020464 · 2002-09-17

ApplicantRolor Electronics Corp.
Decision Date2002-09-17
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646 is the device name listed in this FDA 510(k) record. The listed applicant is Rolor Electronics Corp.. It received FDA 510(k) clearance on 2002-09-17 under 510(k) number K020464. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646?

SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646 is a medical device that received FDA 510(k) clearance on 2002-09-17. The listed applicant is Rolor Electronics Corp.. The 510(k) number is K020464.

When did SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646 receive FDA 510(k) clearance?

SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646 received FDA 510(k) clearance on 2002-09-17, under 510(k) number K020464.

Who is the listed applicant for SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646?

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

What is the FDA product code for SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646?

The FDA product code for SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646 is ILY.

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Other records listing Rolor Electronics 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.

K020130ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016MK021430SANIDAD TENS-DUO MODE GP8016NK020462SANIDAD THERMAL FAR-INFRARED WAVE LAMP, MODEL AP-2018

Related Devices (Code: ILY)

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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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