KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION— 510(k) K083598
Substantially EquivalentKARL STORZ Endoscopy-America, Inc.
FDA 510(k) clearance K083598 for KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION, Substantially Equivalent on 2009-05-29. Applicant: KARL STORZ Endoscopy-America, Inc.. Device class: 2.
Clearance details
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Product code
- Code ODA
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Culver City, CA, US
Recent devices under product code ODA
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