COMPUMEDICS SUMMIT IP— 510(k) K040194
Substantially EquivalentCompumedics USA, Ltd.
FDA 510(k) clearance K040194 for COMPUMEDICS SUMMIT IP, Substantially Equivalent on 2004-04-23. Applicant: Compumedics USA, Ltd.. Device class: 2.
Clearance details
- Applicant
- Compumedics USA, Ltd.
- Product code
- Code MNR
- Device class
- Class 2
- Regulation
- 21 CFR 868.2375
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- El Paso, TX, US
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