The following data is part of a premarket notification filed by Barosense, Inc with the FDA for Barosense Endogastric Tube (egt), Model F0034.
| Device ID | K082589 |
| 510k Number | K082589 |
| Device Name: | BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034 |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | BAROSENSE, INC 3698-C HAVEN AVENUE Redwood City, CA 94063 |
| Contact | Daniel J Balbierz |
| Correspondent | Daniel J Balbierz BAROSENSE, INC 3698-C HAVEN AVENUE Redwood City, CA 94063 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-08 |
| Decision Date | 2009-05-22 |
| Summary: | summary |