The following data is part of a premarket notification filed by Endochoice, Inc. with the FDA for Peerscope System.
| Device ID | K131422 |
| 510k Number | K131422 |
| Device Name: | PEERSCOPE SYSTEM |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| Applicant | ENDOCHOICE, INC. 2 HATOCHEN ST., BUSINESS AND INDUSTRIAL PARK (NORTH) POB 3161 Caesarea, IL 38900 |
| Contact | Tamar Fuerst |
| Correspondent | Tamar Fuerst ENDOCHOICE, INC. 2 HATOCHEN ST., BUSINESS AND INDUSTRIAL PARK (NORTH) POB 3161 Caesarea, IL 38900 |
| Product Code | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-16 |
| Decision Date | 2013-10-10 |
| Summary: | summary |