FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM
K Number: K132205
·
Decision Jun 6, 2014
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
286
Applicant Total
2
Review Days
325
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Basic Information
- Device Name
- ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM
- K Number
- K132205
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5440
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inova Labs, Inc.
- Date Received
- July 16, 2013
- Decision Date
- June 6, 2014
- Product Code
- CAW
- 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 |
|---|---|---|---|
| CAW | Generator, Oxygen, Portable | FDA class 2 | Anesthesiology |
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Other Clearances by Inova Labs, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K113317 | LIFECHOICE OXYGEN CONCENTRATOR | Dec 28, 2011 | Substantially Equivalent |