MODEL ESP-200 MAMMOGRAPHIC SYSTEM— 510(k) K884345
Substantially EquivalentAcoma Medical Imaging, Inc.
FDA 510(k) clearance K884345 for MODEL ESP-200 MAMMOGRAPHIC SYSTEM, Substantially Equivalent on 1989-03-23. Applicant: Acoma Medical Imaging, Inc.. Device class: 2.
Clearance details
- Applicant
- Acoma Medical Imaging, Inc.
- Product code
- Code IZH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1710
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wheeling, IL, US
Recent devices under product code IZH
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