FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ERIS URO-DIAGNOSTIC SYSTEM
K Number: K850169
·
Decision Apr 22, 1985
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
16
Applicant Total
3
Review Days
96
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Basic Information
- Device Name
- ERIS URO-DIAGNOSTIC SYSTEM
- K Number
- K850169
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1800
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Eris Medical Technology
- Date Received
- January 16, 1985
- Decision Date
- April 22, 1985
- Product Code
- FFG
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| FFG | Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | FDA class 2 | Gastroenterology, Urology |
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