MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31— 510(k) K133064

Substantially Equivalent

Envitec-Wismar GmbH

FDA 510(k) clearance K133064 for MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31, Substantially Equivalent on 2014-05-02. Applicant: Envitec-Wismar GmbH.

Clearance details

Applicant: Envitec-Wismar GmbH
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2013-09-27
Decision date: 2014-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Egale, WI, 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.