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 |