PHARMACOKINETICS SOFTWARE SYSTEM (PPS)— 510(k) K864121

Substantially Equivalent

Pharmatrol, Inc.

FDA 510(k) clearance K864121 for PHARMACOKINETICS SOFTWARE SYSTEM (PPS), Substantially Equivalent on 1986-12-10. Applicant: Pharmatrol, Inc..

Clearance details

Applicant: Pharmatrol, Inc.
Product code: Code NDC
Advisory panel: Anesthesiology
Date received: 1986-10-21
Decision date: 1986-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

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Adverse events under product code NDC

product code NDC

Malfunction: 1,390
Total: 1,390

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.