FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
MINISPIR; SPIROLAB III
K Number: K061875
·
Decision Dec 11, 2006
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
227
Applicant Total
10
Review Days
161
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Basic Information
- Device Name
- MINISPIR; SPIROLAB III
- K Number
- K061875
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1840
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mir Medical Intl. Research Srl
- Date Received
- July 3, 2006
- Decision Date
- December 11, 2006
- Product Code
- BZG
- 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 |
|---|---|---|---|
| BZG | Spirometer, Diagnostic | FDA class 2 | Anesthesiology |
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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 |
| K081033 | MIROXI | Jan 15, 2009 | Substantially Equivalent |
| K082766 | MODIFICATION TO MINISPIR, SPIROLAB III | Dec 17, 2008 | Substantially Equivalent |
| K072979 | SPIROBANK G | Dec 26, 2007 | 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 |