The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Broncho-fiberscope.
| Device ID | K832010 |
| 510k Number | K832010 |
| Device Name: | BRONCHO-FIBERSCOPE |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-23 |
| Decision Date | 1983-08-01 |