STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031— 510(k) K043004
Substantially EquivalentViasys 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. Device class: 2.
Clearance details
- Applicant
- Viasys Medsystems
- Product code
- Code FYA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wheeling, IL, US
Recent devices under product code FYA
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More clearances from Viasys Medsystems
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