The following data is part of a premarket notification filed by Oridion Medical 1987 Ltd. with the FDA for Mac-line Co2 Nasal Cannula Sample Line.
Device ID | K012391 |
510k Number | K012391 |
Device Name: | MAC-LINE CO2 NASAL CANNULA SAMPLE LINE |
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 | Sanford Brown |
Correspondent | Sanford 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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-07-27 |
Decision Date | 2001-08-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20884521551760 | K012391 | 000 |