QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100— 510(k) K083079

Substantially Equivalent

Quanta Computer, Inc.

FDA 510(k) clearance K083079 for QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100, Substantially Equivalent on 2009-03-05. Applicant: Quanta Computer, Inc..

Clearance details

Applicant: Quanta Computer, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2008-10-16
Decision date: 2009-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, 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.