FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMT NANOCATH
K Number: K050557
·
Decision May 27, 2005
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
74
Applicant Total
1
Review Days
85
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Basic Information
- Device Name
- AMT NANOCATH
- K Number
- K050557
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5120
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- American Medical Technologies, Inc.
- Date Received
- March 3, 2005
- Decision Date
- May 27, 2005
- Product Code
- BSO
- 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 |
|---|---|---|---|
| BSO | Catheter, Conduction, Anesthetic | FDA class 2 | Anesthesiology |
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