SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)— 510(k) K960614

Substantially Equivalent

Somanetics Corp.

FDA 510(k) clearance K960614 for SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS), Substantially Equivalent on 1996-06-05. Applicant: Somanetics Corp..

Clearance details

Applicant: Somanetics Corp.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 1996-02-13
Decision date: 1996-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Troy, MI, 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.