CHEMO-SPIKE II RECONSTITUTION DEVICE— 510(k) K974431

Substantially Equivalent

Medi-Dose, Inc.

FDA 510(k) clearance K974431 for CHEMO-SPIKE II RECONSTITUTION DEVICE, Substantially Equivalent on 1998-01-08. Applicant: Medi-Dose, Inc..

Clearance details

Applicant: Medi-Dose, Inc.
Product code: Code LHI
Advisory panel: General Hospital
Date received: 1997-11-24
Decision date: 1998-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warminster, PA, US

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Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.