The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Storm-base 2.0.
| Device ID | K093603 |
| 510k Number | K093603 |
| Device Name: | STORM-BASE 2.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo, CA 90245 |
| Contact | Leigh Spotten |
| Correspondent | Leigh Spotten KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo, CA 90245 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-20 |
| Decision Date | 2010-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630039100803 | K093603 | 000 |