HEARTRAK SMART AT/HEARTRAK SMART2— 510(k) K033451
Substantially EquivalentUniversal Medical, Inc.
FDA 510(k) clearance K033451 for HEARTRAK SMART AT/HEARTRAK SMART2, Substantially Equivalent on 2004-02-05. Applicant: Universal Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Universal Medical, Inc.
- 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
- Special
- Location
- Philadelphia, PA, US
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