FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Babyleo TN500
K Number: K162821
·
Decision Jun 23, 2017
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
84
Applicant Total
8
Review Days
259
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Basic Information
- Device Name
- Babyleo TN500
- K Number
- K162821
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5400
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Draegerwerk AG & CO Kgaa
- Date Received
- October 7, 2016
- Decision Date
- June 23, 2017
- Product Code
- FMZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMZ | Incubator, Neonatal | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMZ), ordered by most recent decision date.
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Babyleo TN500
FDA 510(k)
FDA Class 2
·General Hospital
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| K222024 | Evita V800, Evita V600 | May 16, 2023 | Substantially Equivalent |
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| K221118 | CO2 Mainstream Sensor | Apr 5, 2023 | Substantially Equivalent |
| K093633 | INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE | Mar 30, 2010 | Substantially Equivalent |