The following data is part of a premarket notification filed by Oridion Medical 1987 Ltd. with the FDA for Microcap Plus/npb-75.
Device ID | K024300 |
510k Number | K024300 |
Device Name: | MICROCAP PLUS/NPB-75 |
Classification | Oximeter |
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 | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-24 |
Decision Date | 2003-04-03 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10884521582507 | K024300 | 000 |
10884521582545 | K024300 | 000 |
10884521520790 | K024300 | 000 |