FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
NEVA SYSTEM
K Number: K980627
·
Decision Apr 7, 1998
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
25
Applicant Total
3
Review Days
48
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Basic Information
- Device Name
- NEVA SYSTEM
- K Number
- K980627
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Urometrics, Inc.
- Date Received
- February 18, 1998
- Decision Date
- April 7, 1998
- Product Code
- LIL
- Advisory Committee
- Unknown
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| LIL | Monitor, Penile Tumescence | FDA unclassified | Unknown |
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