URETHRAL PRESSURE PROFILE & TEMP. MODUL— 510(k) K823561
Substantially EquivalentNihon Kohden America, Inc.
FDA 510(k) clearance K823561 for URETHRAL PRESSURE PROFILE & TEMP. MODUL, Substantially Equivalent on 1983-01-07. Applicant: Nihon Kohden America, Inc.. Device class: 2.
Clearance details
- Applicant
- Nihon Kohden America, Inc.
- Product code
- Code FAP
- Device class
- Class 2
- Regulation
- 21 CFR 876.1620
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Foothill, CA, US
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