HEWLETT-PACKARD MODELS 78354A & 78352A PULSE OXI.— 510(k) K881136

Substantially Equivalent

Hewlett-Packard Co.

FDA 510(k) clearance K881136 for HEWLETT-PACKARD MODELS 78354A & 78352A PULSE OXI., Substantially Equivalent on 1988-05-18. Applicant: Hewlett-Packard Co..

Clearance details

Applicant: Hewlett-Packard Co.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 1988-03-16
Decision date: 1988-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.