The following data is part of a premarket notification filed by Oridion Medical 1987 Ltd. with the FDA for Validation Of The Breathid System, For The Detection Of Helicbactor Pylori.
| Device ID | K011668 |
| 510k Number | K011668 |
| Device Name: | VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI |
| Classification | Test, Urea (breath Or Blood) |
| Applicant | ORIDION MEDICAL 1987 LTD. 7 HAMARPE ST. P.O. BOX 45025 HAR HOTZVIM INDUSTRIAL PARK Jerusalem, IL 91450 |
| Contact | Sandy Brown |
| Correspondent | Sandy Brown ORIDION MEDICAL 1987 LTD. 7 HAMARPE ST. P.O. BOX 45025 HAR HOTZVIM INDUSTRIAL PARK Jerusalem, IL 91450 |
| Product Code | MSQ |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-17 |
| Decision Date | 2001-07-09 |
| Summary: | summary |