The following data is part of a premarket notification filed by Barosense, Inc with the FDA for Barosense Endogastric Tube And Introducer Bougie.
| Device ID | K120126 |
| 510k Number | K120126 |
| Device Name: | BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | BAROSENSE, INC 250 CHESAPEAKE DRIVE Redwood City, CA 94063 |
| Contact | Shelia Stevens, Phd |
| Correspondent | Shelia Stevens, Phd BAROSENSE, INC 250 CHESAPEAKE DRIVE Redwood City, CA 94063 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-17 |
| Decision Date | 2012-09-10 |
| Summary: | summary |