The following data is part of a premarket notification filed by Oridion Medical 1987 Ltd. with the FDA for Smart Bitebloc.
| Device ID | K042665 |
| 510k Number | K042665 |
| Device Name: | SMART BITEBLOC |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| 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 | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-29 |
| Decision Date | 2004-11-23 |
| Summary: | summary |