FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX
K Number: K120577
·
Decision Jun 24, 2015
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
227
Applicant Total
2
Review Days
1213
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Basic Information
- Device Name
- MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX
- K Number
- K120577
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1840
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medikro OY
- Date Received
- February 27, 2012
- Decision Date
- June 24, 2015
- 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 Medikro OY
| K Number | Device Name | ||
|---|---|---|---|
| K133428 | MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO | May 21, 2014 | Substantially Equivalent |