The following data is part of a premarket notification filed by Hospitech Respiration Ltd. with the FDA for Anapnoguard Endotracheal Tube.
| Device ID | K093126 |
| 510k Number | K093126 |
| Device Name: | ANAPNOGUARD ENDOTRACHEAL TUBE |
| Classification | Dropper, Ether |
| Applicant | HOSPITECH RESPIRATION LTD. 31 HAAVODA ST Binyamina, IL 30500 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy HOSPITECH RESPIRATION LTD. 31 HAAVODA ST Binyamina, IL 30500 |
| Product Code | BTP |
| CFR Regulation Number | 868.5420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-02 |
| Decision Date | 2010-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27290015409166 | K093126 | 000 |
| 27290015409159 | K093126 | 000 |
| 27290015409128 | K093126 | 000 |