SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AND 300103, S200A-090101 AND 300101— 510(k) K061931

Substantially Equivalent

Solaris Medical Technology, Inc.

FDA 510(k) clearance K061931 for SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AND 300103, S200A-090101 AND 300101, Substantially Equivalent on 2007-01-31. Applicant: Solaris Medical Technology, Inc..

Clearance details

Applicant: Solaris Medical Technology, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2006-07-07
Decision date: 2007-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Las Vegas, NV, 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.