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 |