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FDA 510(k)

INFRARAX DEVICE

K-Number: K850852 · 1985-08-21

ApplicantMedicon, Inc.
Decision Date1985-08-21
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

INFRARAX DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Medicon, Inc.. It received FDA 510(k) clearance on 1985-08-21 under 510(k) number K850852. 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 INFRARAX DEVICE?

INFRARAX DEVICE is a medical device that received FDA 510(k) clearance on 1985-08-21. The listed applicant is Medicon, Inc.. The 510(k) number is K850852.

When did INFRARAX DEVICE receive FDA 510(k) clearance?

INFRARAX DEVICE received FDA 510(k) clearance on 1985-08-21, under 510(k) number K850852.

Who is the listed applicant for INFRARAX DEVICE?

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

What is the FDA product code for INFRARAX DEVICE?

The FDA product code for INFRARAX DEVICE is ILY.

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Other records listing Medicon, Inc. as applicant

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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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