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 |