The following data is part of a premarket notification filed by Hospitech Respiration Ltd. with the FDA for Ag Mass.
| Device ID | K131099 |
| 510k Number | K131099 |
| Device Name: | AG MASS |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| 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 | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-19 |
| Decision Date | 2013-05-13 |
| Summary: | summary |