KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II— 510(k) K983626
Substantially EquivalentAlaris Medical Systems, Inc.
FDA 510(k) clearance K983626 for KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II, Substantially Equivalent on 1999-02-05. Applicant: Alaris Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Alaris Medical 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
- Abbreviated
- Location
- Hillsboro, OR, US
Recent devices under product code DXH
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- K032147 — SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES
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