LOOP RECORDER VITAPHONE, 3100 SERIES— 510(k) K053378
Substantially EquivalentTms Telemedizinische Systeme GmbH
FDA 510(k) clearance K053378 for LOOP RECORDER VITAPHONE, 3100 SERIES, Substantially Equivalent on 2006-02-23. Applicant: Tms Telemedizinische Systeme GmbH. Device class: 2.
Clearance details
- Applicant
- Tms Telemedizinische Systeme GmbH
- Product code
- Code DXH
- Device class
- Class 2
- Regulation
- 21 CFR 870.2920
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chemnitz, DE
Recent devices under product code DXH
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