Celesteion, PCA-9000A/3— 510(k) K170490
Substantially EquivalentToshibamedical Systems Corporation
FDA 510(k) clearance K170490 for Celesteion, PCA-9000A/3, Substantially Equivalent on 2017-06-01. Applicant: Toshibamedical Systems Corporation. Device class: 2.
Clearance details
- Applicant
- Toshibamedical Systems Corporation
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Otawara-Shi, JP
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