PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL— 510(k) K062455

Substantially Equivalent

Philips Medical Systems

FDA 510(k) clearance K062455 for PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL, Substantially Equivalent on 2006-11-03. Applicant: Philips Medical Systems.

Clearance details

Applicant: Philips Medical Systems
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2006-08-23
Decision date: 2006-11-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Andover, MA, US

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.