DIGITAL DISK RECORDER— 510(k) K933115
Substantially EquivalentEigen
FDA 510(k) clearance K933115 for DIGITAL DISK RECORDER, Substantially Equivalent on 1994-04-07. Applicant: Eigen. Device class: 1.
Clearance details
- Applicant
- Eigen
- Product code
- Code LMB
- Device class
- Class 1
- Regulation
- 21 CFR 892.2010
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nevada City, CA, US
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