TOMTECP90— 510(k) K950279
Substantially EquivalentTomtec Imaging Systems, Inc.
FDA 510(k) clearance K950279 for TOMTECP90, Substantially Equivalent on 1995-09-15. Applicant: Tomtec Imaging Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Tomtec Imaging Systems, Inc.
- 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
- Boulder, CO, US
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