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FDA 510(k)

PSORALITE 12800 SERIES

K-Number: K864510 · 1987-02-04

ApplicantPsoralite Corp.
Decision Date1987-02-04
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PSORALITE 12800 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Psoralite Corp.. It received FDA 510(k) clearance on 1987-02-04 under 510(k) number K864510. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PSORALITE 12800 SERIES?

PSORALITE 12800 SERIES is a medical device that received FDA 510(k) clearance on 1987-02-04. The listed applicant is Psoralite Corp.. The 510(k) number is K864510.

When did PSORALITE 12800 SERIES receive FDA 510(k) clearance?

PSORALITE 12800 SERIES received FDA 510(k) clearance on 1987-02-04, under 510(k) number K864510.

Who is the listed applicant for PSORALITE 12800 SERIES?

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

What is the FDA product code for PSORALITE 12800 SERIES?

The FDA product code for PSORALITE 12800 SERIES is FTC.

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Other records listing Psoralite 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.

K913760PSORALITE , PHOTOTHERAPY TREATMENT EQUIPMENTK890084PSORALITE PHOTOTHERAPY TREATMENT BOOTH, MDL 45000K881385PSORALITE PHOTOTHERAPY TREATMENT BOOTH/PANELK864511PSORALITE 18400 SERIES

Related Devices (Code: FTC)

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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