INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION— 510(k) K031745

Substantially Equivalent

Sensor Medics Corp.

FDA 510(k) clearance K031745 for INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION, Substantially Equivalent on 2004-02-13. Applicant: Sensor Medics Corp..

Clearance details

Applicant: Sensor Medics Corp.
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2003-06-05
Decision date: 2004-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yorba Linda, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

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.