FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OMNI OXYGEN SYSTEM, MODEL 1000
K Number: K013931
·
Decision Mar 27, 2002
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
286
Applicant Total
4
Review Days
119
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Basic Information
- Device Name
- OMNI OXYGEN SYSTEM, MODEL 1000
- K Number
- K013931
- 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
- November 28, 2001
- Decision Date
- March 27, 2002
- 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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