BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM— 510(k) K040068

Substantially Equivalent

Ohmeda Medical

FDA 510(k) clearance K040068 for BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM, Substantially Equivalent on 2004-04-16. Applicant: Ohmeda Medical.

Clearance details

Applicant: Ohmeda Medical
Product code: Code FMZ
Advisory panel: General Hospital
Date received: 2004-01-14
Decision date: 2004-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laurel, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMZ

product code FMZ

Death: 2
Malfunction: 457
Other: 1
Total: 460

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.