FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 350G GAS CONSERVER
K Number: K090421
·
Decision May 29, 2009
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
70
Applicant Total
2
Review Days
100
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Basic Information
- Device Name
- MODEL 350G GAS CONSERVER
- K Number
- K090421
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inspired Technologies, Inc.
- Date Received
- February 18, 2009
- Decision Date
- May 29, 2009
- Product Code
- NFB
- 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 |
|---|---|---|---|
| NFB | Conserver, Oxygen | FDA class 2 | Anesthesiology |
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Other Clearances by Inspired Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K082853 | CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR | Mar 23, 2009 | Substantially Equivalent |