ES 1500 ECG DEMODULATOR— 510(k) K921699
Substantially EquivalentEpic Systems, Inc.
FDA 510(k) clearance K921699 for ES 1500 ECG DEMODULATOR, Substantially Equivalent on 1992-12-17. Applicant: Epic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Epic Systems, 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
- Traditional
- Location
- Darby, MT, US
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