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FDA 510(k)

PHARMACOKINETICS SOFTWARE SYSTEM (PPS)

K-Number: K864121 · 1986-12-10

ApplicantPharmatrol, Inc.
Decision Date1986-12-10
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PHARMACOKINETICS SOFTWARE SYSTEM (PPS) is the device name listed in this FDA 510(k) record. The listed applicant is Pharmatrol, Inc.. It received FDA 510(k) clearance on 1986-12-10 under 510(k) number K864121. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHARMACOKINETICS SOFTWARE SYSTEM (PPS)?

PHARMACOKINETICS SOFTWARE SYSTEM (PPS) is a medical device that received FDA 510(k) clearance on 1986-12-10. The listed applicant is Pharmatrol, Inc.. The 510(k) number is K864121.

When did PHARMACOKINETICS SOFTWARE SYSTEM (PPS) receive FDA 510(k) clearance?

PHARMACOKINETICS SOFTWARE SYSTEM (PPS) received FDA 510(k) clearance on 1986-12-10, under 510(k) number K864121.

Who is the listed applicant for PHARMACOKINETICS SOFTWARE SYSTEM (PPS)?

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

What is the FDA product code for PHARMACOKINETICS SOFTWARE SYSTEM (PPS)?

The FDA product code for PHARMACOKINETICS SOFTWARE SYSTEM (PPS) is NDC.

Related Clinical Trials

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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Related Devices (Code: NDC)

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.

K254102GlucommanderGlytec, LLCK260910EndoTool IV Cloud 1.0Glooko, Inc.K253512MiniMed Go AppMedtronic MinimedK253281UpDocUpdoc, Inc.K252104T1D1Comerge AGK241088EndoTool IV (3.1)Monarch Medical Technologies

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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