BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM— 510(k) K993712

Substantially Equivalent

Ohmeda Medical

FDA 510(k) clearance K993712 for BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM, Substantially Equivalent on 1999-11-09. Applicant: Ohmeda Medical.

Clearance details

Applicant: Ohmeda Medical
Product code: Code FMZ
Advisory panel: General Hospital
Date received: 1999-11-03
Decision date: 1999-11-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Columbia, MD, US

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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.