The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Image1 Spies.
| Device ID | K131953 |
| 510k Number | K131953 |
| Device Name: | IMAGE1 SPIES |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVENUE El Segundo, CA 90245 |
| Contact | Winkie Wong |
| Correspondent | Winkie Wong KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVENUE El Segundo, CA 90245 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-27 |
| Decision Date | 2013-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551333150 | K131953 | 000 |
| 04048551337660 | K131953 | 000 |
| 04048551379103 | K131953 | 000 |
| 04048551356517 | K131953 | 000 |