FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
Antistatic Compact Space Chamber
K Number: K143615
·
Decision Jan 26, 2016
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
15
Applicant Total
1
Review Days
403
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Basic Information
- Device Name
- Antistatic Compact Space Chamber
- K Number
- K143615
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Developments International Limited
- Date Received
- December 19, 2014
- Decision Date
- January 26, 2016
- 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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