FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC)
K Number: K112010
·
Decision Jul 11, 2012
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
15
Applicant Total
12
Review Days
363
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Basic Information
- Device Name
- AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC)
- K Number
- K112010
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Trudell Medical Intl.
- Date Received
- July 14, 2011
- Decision Date
- July 11, 2012
- Product Code
- NVP
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| NVP | Holding Chambers, Direct Patient Interface | FDA class 2 | Anesthesiology |
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