MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A)— 510(k) K971910

Substantially Equivalent

Hewlett-Packard GmbH

FDA 510(k) clearance K971910 for MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A), Substantially Equivalent on 1998-03-23. Applicant: Hewlett-Packard GmbH.

Clearance details

Applicant: Hewlett-Packard GmbH
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 1997-05-23
Decision date: 1998-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuerttemberg, DE

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Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.