FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
ASSISTO ARM SYSTEMS
K Number: K052745
·
Decision Nov 23, 2005
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
92
Applicant Total
2
Review Days
54
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Basic Information
- Device Name
- ASSISTO ARM SYSTEMS
- K Number
- K052745
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1480
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Geomed Medizin-Technik GmbH & Co.
- Date Received
- September 30, 2005
- Decision Date
- November 23, 2005
- Product Code
- GWG
- 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 |
|---|---|---|---|
| GWG | Endoscope, Neurological | FDA class 2 | Neurology |
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Other Clearances by Geomed Medizin-Technik GmbH & Co.
| K Number | Device Name | ||
|---|---|---|---|
| K183438 | Geomed Vascular Dilators | Sep 3, 2019 | Substantially Equivalent |