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

Clearance details

Applicant

Envitec-Wismar GmbH

Product code

Code DQA

Device class

Class 2

Regulation

21 CFR 870.2700

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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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 →