Karl Storz UROMAT E.A.S.I.— 510(k) K162992
Substantially EquivalentKarl Storz Endoscopy America, Inc.
FDA 510(k) clearance K162992 for Karl Storz UROMAT E.A.S.I., Substantially Equivalent on 2017-07-07. Applicant: Karl Storz Endoscopy America, Inc.. Device class: 2.
Clearance details
- Applicant
- Karl Storz Endoscopy America, Inc.
- Product code
- Code LJH
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- El Segundo, CA, US
Recent devices under product code LJH
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