FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR
K Number: K070674
·
Decision Apr 11, 2007
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
15
Applicant Total
12
Review Days
30
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Basic Information
- Device Name
- AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR
- K Number
- K070674
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Trudell Medical Intl.
- Date Received
- March 12, 2007
- Decision Date
- April 11, 2007
- 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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