URINARY DRAINAGE MONITORING SYSTEM— 510(k) K780134
Substantially EquivalentMedical Devices, Inc.
FDA 510(k) clearance K780134 for URINARY DRAINAGE MONITORING SYSTEM, Substantially Equivalent on 1978-02-02. Applicant: Medical Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- Medical Devices, Inc.
- Product code
- Code FCN
- Device class
- Class 2
- Regulation
- 21 CFR 876.5250
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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