Pulse oximeter NBM-200— 510(k) K142209

Substantially Equivalent

Orsense, Ltd.

FDA 510(k) clearance K142209 for Pulse oximeter NBM-200, Substantially Equivalent on 2015-01-16. Applicant: Orsense, Ltd..

Clearance details

Applicant: Orsense, Ltd.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2014-08-11
Decision date: 2015-01-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Petah-Tikva, IL

Download summary PDF View on FDA.gov ↗

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.