The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Nasopharyngoscopes, Bronchoscopes, Tracheoscp[es And Esophagoscopes, Laryngoscopes, Oto-telescopes.
| Device ID | K945381 |
| 510k Number | K945381 |
| Device Name: | NASOPHARYNGOSCOPES, BRONCHOSCOPES, TRACHEOSCP[ES AND ESOPHAGOSCOPES, LARYNGOSCOPES, OTO-TELESCOPES |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Betty M Johnson |
| Correspondent | Betty M Johnson KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-02 |
| Decision Date | 1995-01-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551268049 | K945381 | 000 |