APPRAISE-HRI— 510(k) K233249
Substantially EquivalentThe Surgeon General, Department of the Army (TSG-DA)
FDA 510(k) clearance K233249 for APPRAISE-HRI, Substantially Equivalent on 2024-04-05. Applicant: The Surgeon General, Department of the Army (TSG-DA). Device class: 2.
Clearance details
- Applicant
- The Surgeon General, Department of the Army (TSG-DA)
- Product code
- Code SAR
- Device class
- Class 2
- Regulation
- 21 CFR 870.2220
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Dietrick, MD, US
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