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 |