The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Voice1 Scb R-ui Speech Control Application.
| Device ID | K083598 |
| 510k Number | K083598 |
| Device Name: | KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION |
| Classification | Endoscopic Central Control Unit |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Crystal Dizol |
| Correspondent | Crystal Dizol KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | ODA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-05 |
| Decision Date | 2009-05-29 |
| Summary: | summary |