FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
MIROXI
K Number: K081033
·
Decision Jan 15, 2009
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
10
Review Days
279
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Basic Information
- Device Name
- MIROXI
- K Number
- K081033
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mir Medical Intl. Research Srl
- Date Received
- April 11, 2008
- Decision Date
- January 15, 2009
- Product Code
- DQA
- Advisory Committee
- Cardiovascular
- 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 |
|---|---|---|---|
| DQA | Oximeter | FDA class 2 | Cardiovascular |
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Other Clearances by Mir Medical Intl. Research Srl
| K Number | Device Name | ||
|---|---|---|---|
| K130784 | SPIROTEL | Oct 30, 2013 | Substantially Equivalent |
| K122384 | MINISPIR | Oct 4, 2012 | Substantially Equivalent |
| K082766 | MODIFICATION TO MINISPIR, SPIROLAB III | Dec 17, 2008 | Substantially Equivalent |
| K072979 | SPIROBANK G | Dec 26, 2007 | Substantially Equivalent |
| K061875 | MINISPIR; SPIROLAB III | Dec 11, 2006 | Substantially Equivalent |
| K061712 | SPIROBANK II | Dec 1, 2006 | Substantially Equivalent |
| K052140 | SPIROLAB, SPIROLAB II | Mar 16, 2006 | Substantially Equivalent |
| K043528 | SPIROTEL | Jul 19, 2005 | Substantially Equivalent |
| K983909 | MIR SPIROBANK SPIROMETER | Dec 21, 1998 | Substantially Equivalent |