FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELAN 4 Air Motor System
K Number: K172907
·
Decision Nov 9, 2018
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
26
Applicant Total
207
Review Days
410
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Basic Information
- Device Name
- ELAN 4 Air Motor System
- K Number
- K172907
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4370
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aesculap, Inc.
- Date Received
- September 25, 2017
- Decision Date
- November 9, 2018
- Product Code
- HBB
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HBB | Motor, Drill, Pneumatic | FDA class 2 | Neurology |
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