iProvèn - Oximeter
2026-03-09
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014015501 | 3014015501 | SEVENGROUND TRADING B.V. | 1 | N | 2026-01-01 | Amstelwijckweg 15 Dordrecht Zuid-Holland NL NL-3316 BB |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 08719699630161 | iProvèn - Oximeters, able to measure oxygen level of the blood | 18555178225 | inventorym@masenainvest.com |
| 08719699636644 | iProvèn - BBB-112 Grey is a heating pad | 18555178225 | jenille.rabeje@sevenground.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 211824 | 1627124458 | K182652 | COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10 | FLL | 2018-11-20 |
| 211824 | 1701328914 | K181551 | DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette | LCX | 2019-02-22 |
| 211824 | 1845177699 | K181215 | Infrared Thermometer | FLL | 2019-01-02 |
| 211824 | 1374776256 | K172795 | Infrared Thermometer | FLL | 2018-03-14 |
| 211824 | 1213454375 | K172627 | David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette | LCX | 2018-03-28 |
| 211824 | 1576654785 | K171888 | Non-contact infrared body thermometer | FLL | 2018-07-23 |
| 211824 | 1294086336 | K163518 | Digital Thermometer | FLL | 2017-09-19 |
| 211824 | 1267903128 | K153149 | Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36 | FLL | 2016-05-27 |
| 211824 | 1212307615 | K140582 | FINGERTIP PULSE OXIMETER | DQA | 2014-08-28 |
| 211824 | 1455994874 | K132085 | ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM | LCX | 2013-11-12 |
| 211824 | 1949732210 | K131395 | TRANSTEK BLOOD PRESSURE MONITOR | DXN | 2013-06-19 |
| 211824 | 1093689701 | K131243 | NON-CONTACT INFRARED THERMOMETER | FLL | 2013-11-12 |
| 211824 | 1238317793 | K123669 | TRANSTEK WRIST BLOOD PRESSURE MONITOR | DXN | 2012-12-21 |
| 211824 | 2068824850 | K122912 | DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER) | FLL | 2012-11-07 |
| 211824 | 1258832347 | K122482 | TRANSTEK WRIST BLOOD PRESSURE MONITOR | DXN | 2012-10-22 |
| 211824 | 1666059035 | K120058 | TRANSTEK BLOOD PRESSURE MONITOR | DXN | 2012-01-31 |
| 211824 | 1540485462 | K112042 | KINGYIELD WRIST BLOOD PRESSURE MONITOR | DXN | 2012-02-10 |
| 211824 | 1111150981 | K092447 | DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES | FLL | 2010-01-07 |
| 211824 | 1093748136 | K062033 | BP 101 DIGITAL BLOOD PRESSURE MONITOR | DXN | 2007-03-23 |
| 211824 | 1530952001 | K060019 | ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM) | LCX | 2006-02-17 |
| 211824 | 1825349983 | K053236 | DAVID PREGNANCY TEST (MIDSTREAM) | LCX | 2006-07-18 |
| 211824 | 1045744661 |
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