FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OMNI 2 OXYGEN SYSTEM
K Number: K083163
·
Decision Oct 20, 2009
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
286
Applicant Total
4
Review Days
358
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Basic Information
- Device Name
- OMNI 2 OXYGEN SYSTEM
- K Number
- K083163
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5440
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sequal Technologies, Inc.
- Date Received
- October 27, 2008
- Decision Date
- October 20, 2009
- 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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