CORE MONITORING SYSTEM-SP1475/6275/5607/5708/4575— 510(k) K921727
Substantially EquivalentViggo-Spectramed
FDA 510(k) clearance K921727 for CORE MONITORING SYSTEM-SP1475/6275/5607/5708/4575, Substantially Equivalent on 1994-05-10. Applicant: Viggo-Spectramed. Device class: 2.
Clearance details
- Applicant
- Viggo-Spectramed
- Product code
- Code KNF
- Device class
- Class 2
- Regulation
- 21 CFR 884.4160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oxnard, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.