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FDA 510(k)

POLAROID HELIOS LASER IMAGER

K-Number: K912073 · 1991-08-28

ApplicantPolaroid Medical Corp.
Decision Date1991-08-28
Product CodeLMC
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

POLAROID HELIOS LASER IMAGER is the device name listed in this FDA 510(k) record. The listed applicant is Polaroid Medical Corp.. It received FDA 510(k) clearance on 1991-08-28 under 510(k) number K912073. The device is classified under product code LMC. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLAROID HELIOS LASER IMAGER?

POLAROID HELIOS LASER IMAGER is a medical device that received FDA 510(k) clearance on 1991-08-28. The listed applicant is Polaroid Medical Corp.. The 510(k) number is K912073.

When did POLAROID HELIOS LASER IMAGER receive FDA 510(k) clearance?

POLAROID HELIOS LASER IMAGER received FDA 510(k) clearance on 1991-08-28, under 510(k) number K912073.

Who is the listed applicant for POLAROID HELIOS LASER IMAGER?

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

What is the FDA product code for POLAROID HELIOS LASER IMAGER?

The FDA product code for POLAROID HELIOS LASER IMAGER is LMC.

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Related Devices (Code: LMC)

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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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