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FDA 510(k)

PSORALITE 18400 SERIES

K-Number: K864511 · 1987-02-04

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

Device Summary

PSORALITE 18400 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 K864511. 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 18400 SERIES?

PSORALITE 18400 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 K864511.

When did PSORALITE 18400 SERIES receive FDA 510(k) clearance?

PSORALITE 18400 SERIES received FDA 510(k) clearance on 1987-02-04, under 510(k) number K864511.

Who is the listed applicant for PSORALITE 18400 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 18400 SERIES?

The FDA product code for PSORALITE 18400 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/PANELK864510PSORALITE 12800 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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