FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
MESA OXYGEN CONCENTRATOR, MODEL 2-6000 SERIES
K Number: K091541
·
Decision Dec 31, 2009
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
286
Applicant Total
2
Review Days
219
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Basic Information
- Device Name
- MESA OXYGEN CONCENTRATOR, MODEL 2-6000 SERIES
- K Number
- K091541
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 868.5440
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sequal Technologies Co., Ltd.
- Date Received
- May 26, 2009
- Decision Date
- December 31, 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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Other Clearances by Sequal Technologies Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K100920 | MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES | Nov 29, 2010 | Substantially Equivalent |