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FDA 510(k)

IMATION SE-204 LASER IMAGER

K-Number: K972822 · 1997-11-19

ApplicantImation Enterprises Corp.
Decision Date1997-11-19
Product CodeLMC
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMATION SE-204 LASER IMAGER is the device name listed in this FDA 510(k) record. The listed applicant is Imation Enterprises Corp.. It received FDA 510(k) clearance on 1997-11-19 under 510(k) number K972822. 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 IMATION SE-204 LASER IMAGER?

IMATION SE-204 LASER IMAGER is a medical device that received FDA 510(k) clearance on 1997-11-19. The listed applicant is Imation Enterprises Corp.. The 510(k) number is K972822.

When did IMATION SE-204 LASER IMAGER receive FDA 510(k) clearance?

IMATION SE-204 LASER IMAGER received FDA 510(k) clearance on 1997-11-19, under 510(k) number K972822.

Who is the listed applicant for IMATION SE-204 LASER IMAGER?

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

What is the FDA product code for IMATION SE-204 LASER IMAGER?

The FDA product code for IMATION SE-204 LASER IMAGER is LMC.

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Related Devices (Code: LMC)

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.

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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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