The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Trans-nasal Esophagoscope.
| Device ID | K051972 |
| 510k Number | K051972 |
| Device Name: | KARL STORZ TRANS-NASAL ESOPHAGOSCOPE |
| Classification | Esophagoscope (flexible Or Rigid) |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Yvonne Fernandez |
| Correspondent | Yvonne Fernandez KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | EOX |
| CFR Regulation Number | 874.4710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-21 |
| Decision Date | 2005-08-15 |
| Summary: | summary |