DOWNSCAN LT— 510(k) K974882
Substantially EquivalentMerlin Engineering Works, Inc.
FDA 510(k) clearance K974882 for DOWNSCAN LT, Substantially Equivalent on 1998-05-22. Applicant: Merlin Engineering Works, Inc.. Device class: 1.
Clearance details
- Applicant
- Merlin Engineering Works, Inc.
- Product code
- Code LMD
- Device class
- Class 1
- Regulation
- 21 CFR 892.2020
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palo Alto, CA, US
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