CRC-77tHR— 510(k) K162394
Substantially EquivalentCapintec, Inc.
FDA 510(k) clearance K162394 for CRC-77tHR, Substantially Equivalent on 2017-03-08. Applicant: Capintec, Inc.. Device class: 2.
Clearance details
- Applicant
- Capintec, Inc.
- Product code
- Code KPT
- Device class
- Class 2
- Regulation
- 21 CFR 892.1360
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Florham Park, NJ, US
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