DC-1 I.V. DOSAGE COMPUTER— 510(k) K884016

Substantially Equivalent

Phase Medical, Inc.

FDA 510(k) clearance K884016 for DC-1 I.V. DOSAGE COMPUTER, Substantially Equivalent on 1988-12-20. Applicant: Phase Medical, Inc..

Clearance details

Applicant: Phase Medical, Inc.
Product code: Code NDC
Advisory panel: Anesthesiology
Date received: 1988-09-22
Decision date: 1988-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, 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.