FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031
K Number: K043004
·
Decision Mar 16, 2005
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
294
Applicant Total
7
Review Days
135
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Basic Information
- Device Name
- STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031
- K Number
- K043004
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Viasys Medsystems
- Date Received
- November 1, 2004
- Decision Date
- March 16, 2005
- Product Code
- FYA
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FYA | Gown, Surgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Viasys Medsystems
| K Number | Device Name | ||
|---|---|---|---|
| K081725 | ENTERAL PUMP SET, MODEL 20-1010 | Nov 7, 2008 | Substantially Equivalent |
| K080679 | MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 | Jun 27, 2008 | Substantially Equivalent |
| K063061 | CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 | Apr 2, 2007 | Substantially Equivalent |
| K043044 | ANTI-I.V. ENTERAL FEEDING SYSTEM | May 6, 2005 | Substantially Equivalent |
| K050309 | PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000 | Mar 25, 2005 | Substantially Equivalent |
| K041987 | CORTRAK | Dec 17, 2004 | Substantially Equivalent |