WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506— 510(k) K022163

Substantially Equivalent

Welch Allyn, Inc.

FDA 510(k) clearance K022163 for WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506, Substantially Equivalent on 2002-09-17. Applicant: Welch Allyn, Inc..

Clearance details

Applicant: Welch Allyn, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2002-07-03
Decision date: 2002-09-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Skaneateles Falls, NY, 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.