FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TruDi Navigation System
K Number: K192397
·
Decision Jan 30, 2020
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
36
Applicant Total
3
Review Days
149
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Basic Information
- Device Name
- TruDi Navigation System
- K Number
- K192397
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biosense Webster
- Date Received
- September 3, 2019
- Decision Date
- January 30, 2020
- Product Code
- PGW
- Advisory Committee
- Neurology
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| PGW | Ear, Nose, And Throat Stereotaxic Instrument | FDA class 2 | Neurology |
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