The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Video Flexible Video Ent Endoscope System.
| Device ID | K071530 |
| 510k Number | K071530 |
| Device Name: | KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Susie Chen |
| Correspondent | Susie Chen 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 | 2007-06-05 |
| Decision Date | 2007-08-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551052266 | K071530 | 000 |
| 04048551052242 | K071530 | 000 |
| 04048551052235 | K071530 | 000 |