CO2mbiLED— 510(k) K201096
Substantially EquivalentKarl Storz Endoscopy America, Inc.
FDA 510(k) clearance K201096 for CO2mbiLED, Substantially Equivalent on 2020-06-23. Applicant: Karl Storz Endoscopy America, Inc.. Device class: 2.
Clearance details
- Applicant
- Karl Storz Endoscopy America, Inc.
- Product code
- Code FCX
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- El Segundo, CA, US
Recent devices under product code FCX
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