WEP 7604 TELEMETRY MONITOR— 510(k) K854369
Substantially EquivalentNihon Kohden America, Inc.
FDA 510(k) clearance K854369 for WEP 7604 TELEMETRY MONITOR, Substantially Equivalent on 1986-02-28. Applicant: Nihon Kohden America, Inc.. Device class: 2.
Clearance details
- Applicant
- Nihon Kohden America, 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
- Irvine, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.