DeviceClearance

STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031— 510(k) K043004

Substantially Equivalent

Viasys Medsystems

FDA 510(k) clearance K043004 for STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031, Substantially Equivalent on 2005-03-16. Applicant: Viasys Medsystems.

Clearance details

Applicant
Viasys Medsystems
Product code
Code FYA
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Wheeling, IL, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.