EpiWatch Monitoring System— 510(k) K243515
Substantially EquivalentEpiwatch, Inc.
FDA 510(k) clearance K243515 for EpiWatch Monitoring System, Substantially Equivalent on 2025-03-07. Applicant: Epiwatch, Inc.. Device class: 2.
Clearance details
- Applicant
- Epiwatch, Inc.
- Product code
- Code POS
- Device class
- Class 2
- Regulation
- 21 CFR 882.1580
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Baltimore, MD, US
Recent devices under product code POS
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