The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Scb/valleylab Force Fx Interface Unit.
| Device ID | K041912 |
| 510k Number | K041912 |
| Device Name: | SCB/VALLEYLAB FORCE FX INTERFACE UNIT |
| Classification | Endoscopic Central Control Unit |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE DRIVE Culver City, CA 90230 -7600 |
| Contact | Susie S Chen |
| Correspondent | Susie S Chen KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE DRIVE 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 | 2004-07-15 |
| Decision Date | 2004-10-25 |
| Summary: | summary |