DIGITIZER, MODEL # 3-000A-1518— 510(k) K922619
Substantially EquivalentLorad Medical Systems, Inc.
FDA 510(k) clearance K922619 for DIGITIZER, MODEL # 3-000A-1518, Substantially Equivalent on 1992-07-01. Applicant: Lorad Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Lorad Medical Systems, 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
- Danbury, CT, US
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