LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE— 510(k) K853059
Substantially EquivalentTridak Division of Indicon, Inc.
FDA 510(k) clearance K853059 for LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE, Substantially Equivalent on 1986-01-10. Applicant: Tridak Division of Indicon, Inc.. Device class: 2.
Clearance details
- Applicant
- Tridak Division of Indicon, 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
- Pearl River, NY, US
Recent devices under product code FAP
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