The following data is part of a premarket notification filed by Hospitech Respiration Ltd. with the FDA for Anapnoguard 100 Respiratory Guard System.
| Device ID | K150157 |
| 510k Number | K150157 |
| Device Name: | AnapnoGuard 100 Respiratory Guard System |
| Classification | Cuff, Tracheal Tube, Inflatable |
| Applicant | HOSPITECH RESPIRATION LTD. 20 HAMAGSHIMIM ST. KIRYAT MATALON Petach Tikva, IL 49348 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy Qsite 31 Haavoda Street Binyamina, IL 30500 |
| Product Code | BSK |
| CFR Regulation Number | 868.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-23 |
| Decision Date | 2016-02-16 |
| Summary: | summary |