CRC PC Smart Chamber K1— 510(k) K192199
Substantially EquivalentCapintec, Inc.
FDA 510(k) clearance K192199 for CRC PC Smart Chamber K1, Substantially Equivalent on 2019-09-12. 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
- Special
- Location
- Florham Park, NJ, US
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