KING OF HEARTS EXPRESS (E.X.) MONITOR— 510(k) K920984
Substantially EquivalentInstromedix, Inc.
FDA 510(k) clearance K920984 for KING OF HEARTS EXPRESS (E.X.) MONITOR, Substantially Equivalent on 1992-10-14. Applicant: Instromedix, Inc.. Device class: 2.
Clearance details
- Applicant
- Instromedix, 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
- Hillsboro, OR, US
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