FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
SpiroScout
K Number: K160116
·
Decision Oct 7, 2016
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
227
Applicant Total
2
Review Days
262
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Basic Information
- Device Name
- SpiroScout
- K Number
- K160116
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1840
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ganshorn Medizin Electronic GmbH
- Date Received
- January 19, 2016
- Decision Date
- October 7, 2016
- 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 Ganshorn Medizin Electronic GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K240706 | PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) | Dec 9, 2024 | Substantially Equivalent |