The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Rhino-laryngo-broncho Fiberscope, Fiberscope For Bronchoscopy.
| Device ID | K954797 |
| 510k Number | K954797 |
| Device Name: | KARL STORZ RHINO-LARYNGO-BRONCHO FIBERSCOPE, FIBERSCOPE FOR BRONCHOSCOPY |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Renate A Maclaren |
| Correspondent | Renate A Maclaren KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-18 |
| Decision Date | 1996-01-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551050279 | K954797 | 000 |
| 04048551049860 | K954797 | 000 |
| 04048551049976 | K954797 | 000 |
| 04048551050002 | K954797 | 000 |
| 04048551050033 | K954797 | 000 |
| 04048551050040 | K954797 | 000 |
| 04048551050187 | K954797 | 000 |
| 04048551050248 | K954797 | 000 |
| 04048551050255 | K954797 | 000 |
| 04048551049853 | K954797 | 000 |