The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Esophagoscope And Accessories.
| Device ID | K943667 |
| 510k Number | K943667 |
| Device Name: | ESOPHAGOSCOPE AND ACCESSORIES |
| Classification | Esophagoscope (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 | EOX |
| CFR Regulation Number | 874.4710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-28 |
| Decision Date | 1994-08-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551227398 | K943667 | 000 |
| 04048551052969 | K943667 | 000 |
| 04048551052952 | K943667 | 000 |
| 04048551052945 | K943667 | 000 |
| 04048551052938 | K943667 | 000 |
| 04048551052921 | K943667 | 000 |
| 04048551052914 | K943667 | 000 |
| 04048551052907 | K943667 | 000 |
| 04048551052891 | K943667 | 000 |
| 04048551052884 | K943667 | 000 |
| 04048551052877 | K943667 | 000 |
| 04048551052860 | K943667 | 000 |
| 04048551052853 | K943667 | 000 |
| 04048551052846 | K943667 | 000 |
| 04048551052839 | K943667 | 000 |
| 04048551052822 | K943667 | 000 |
| 04048551052501 | K943667 | 000 |
| 04048551052976 | K943667 | 000 |
| 04048551052983 | K943667 | 000 |
| 04048551052747 | K943667 | 000 |
| 04048551052730 | K943667 | 000 |
| 04048551052723 | K943667 | 000 |
| 04048551052716 | K943667 | 000 |
| 04048551052709 | K943667 | 000 |
| 04048551052693 | K943667 | 000 |
| 04048551405765 | K943667 | 000 |
| 04048551405758 | K943667 | 000 |
| 04048551405741 | K943667 | 000 |
| 04048551227411 | K943667 | 000 |
| 04048551053270 | K943667 | 000 |
| 04048551053263 | K943667 | 000 |
| 04048551053256 | K943667 | 000 |
| 04048551053249 | K943667 | 000 |
| 04048551053232 | K943667 | 000 |
| 04048551053225 | K943667 | 000 |
| 04048551052471 | K943667 | 000 |