FDA 510(k)

PCI 4000

K-Number: K932610 · 1993-08-19

ApplicantPci

Decision Date1993-08-19

Product CodeIPF

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

PCI 4000 is the device name listed in this FDA 510(k) record. The listed applicant is Pci. It received FDA 510(k) clearance on 1993-08-19 under 510(k) number K932610. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PCI 4000?

PCI 4000 is a medical device that received FDA 510(k) clearance on 1993-08-19. The listed applicant is Pci. The 510(k) number is K932610.

When did PCI 4000 receive FDA 510(k) clearance?

PCI 4000 received FDA 510(k) clearance on 1993-08-19, under 510(k) number K932610.

Who is the listed applicant for PCI 4000?

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

What is the FDA product code for PCI 4000?

The FDA product code for PCI 4000 is IPF.

Other records listing Pci 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.

K933072PCI 2500

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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.