FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
MICRO I
K Number: K113096
·
Decision Apr 13, 2012
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
227
Applicant Total
12
Review Days
177
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Basic Information
- Device Name
- MICRO I
- K Number
- K113096
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1840
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carefusion Germany 234 GmbH
- Date Received
- October 19, 2011
- Decision Date
- April 13, 2012
- 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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| K142959 | Vyntus Walk | Mar 20, 2015 | Substantially Equivalent |
| K141936 | MICROBLAB, MICROLOOP | Dec 29, 2014 | Substantially Equivalent |
| K133925 | VYNTUS/ SENTRYSUITE PRODUCT LINE | Aug 22, 2014 | Substantially Equivalent |
| K122699 | SENTRYSUITE PRODUCT LINE | Nov 19, 2012 | Substantially Equivalent |
| K113813 | SENTRYSUITE PRODUCT LINE | May 10, 2012 | Substantially Equivalent |
| K111408 | MICROGARD II | Oct 17, 2011 | Substantially Equivalent |
| K111053 | SENTRYSUITE PRODUCT LINE | Aug 12, 2011 | Substantially Equivalent |
| K101873 | MASTERSCREEN IOS | Feb 10, 2011 | Substantially Equivalent |