HP ORVUE INTRA-OP (M2510A)— 510(k) K965160

Substantially Equivalent

Hewlett-Packard GmbH

FDA 510(k) clearance K965160 for HP ORVUE INTRA-OP (M2510A), Substantially Equivalent on 1997-09-11. Applicant: Hewlett-Packard GmbH.

Clearance details

Applicant: Hewlett-Packard GmbH
Product code: Code BSZ
Advisory panel: Anesthesiology
Date received: 1996-12-23
Decision date: 1997-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuerttemberg, DE

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Adverse events under product code BSZ

product code BSZ

Death: 23
Injury: 298
Malfunction: 32,987
Total: 33,308

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.