The following data is part of a premarket notification filed by Oridion Medical 1987 Ltd. with the FDA for Microstream External Battery Charger.
| Device ID | K002163 |
| 510k Number | K002163 |
| Device Name: | MICROSTREAM EXTERNAL BATTERY CHARGER |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | ORIDION MEDICAL 1987 LTD. 7 HAMARPE ST. P.O.B. 45025 HAR HOTZVIM INDUSTRIAL PARK Jerusalem, IL 91450 |
| Contact | Sanford Brown |
| Correspondent | Sanford Brown ORIDION MEDICAL 1987 LTD. 7 HAMARPE ST. P.O.B. 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 | 2000-07-18 |
| Decision Date | 2001-01-11 |