The following data is part of a premarket notification filed by Hospitech Respiration Ltd. with the FDA for Ag 100s.
| Device ID | K180991 |
| 510k Number | K180991 |
| Device Name: | AG 100s |
| 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 St. 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 | 2018-04-16 |
| Decision Date | 2018-10-12 |
| Summary: | summary |