APEX 215M MOBILE ANGER CAMERA— 510(k) K884673
Substantially EquivalentElscint, Inc.
FDA 510(k) clearance K884673 for APEX 215M MOBILE ANGER CAMERA, Substantially Equivalent on 1989-04-14. Applicant: Elscint, Inc.. Device class: 1.
Clearance details
- Applicant
- Elscint, Inc.
- Product code
- Code IYX
- Device class
- Class 1
- Regulation
- 21 CFR 892.1100
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boston, MA, US
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