Panels › Cardiovascular › Product code PLB · Class 2
Multivariate Vital Signs Index
Regulation 870.2300
0510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PLB
| Company | 510(k)s | Recalls |
|---|---|---|
| Etiometry, Inc. | 2 | 0 |
| Aitrics Co., Ltd. | 1 | 0 |
| Algodx AB | 1 | 0 |
| Biofourmis Singapore Pte., Ltd. | 1 | 0 |
| Quantitative | 1 | 0 |
| Spass, Inc. | 1 | 0 |
| Vgbio, Inc (Dba Physiq) | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 23, 2024 | K240756 | AITRICS-VC Aitrics Co., Ltd., KR | PLB |
| Jul 22, 2024 | K240558 | NAVOYCDS Algodx AB, SE | PLB |
| Jun 15, 2023 | K230386 | SpassageQ Spass, Inc., KR | PLB |
| Jan 6, 2023 | K213423 | T3 Platform software Etiometry, Inc. | PLB |
| Aug 15, 2019 | K183282 | Biovitals Analytics Engine Biofourmis Singapore Pte., Ltd., SG | PLB |
| Mar 31, 2016 | K152258 | T3 Software Etiometry, Inc. | PLB |
| Jun 11, 2015 | K142512 | Personalized Physiology Analytics Engine software Vgbio, Inc (Dba Physiq) | PLB |
| Sep 26, 1985 | K843905 | TRAUMA CARE EVALUATION Quantitative | PLB |
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