PCI MODEL 2041-A TELEMETRY MONITOR— 510(k) K894340
Substantially EquivalentAccucore, Inc.
FDA 510(k) clearance K894340 for PCI MODEL 2041-A TELEMETRY MONITOR, Substantially Equivalent on 1989-10-02. Applicant: Accucore, Inc.. Device class: 2.
Clearance details
- Applicant
- Accucore, 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
- Santa Ana, CA, US
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