FDA Product Code
FDA Product Code PLB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2300
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K240756 | AITRICS-VC | Aitrics Co., Ltd. | 2024-07-23 | Traditional | PDF ↗ |
| K240558 | NAVOYCDS | Algodx AB | 2024-07-22 | Traditional | PDF ↗ |
| K230386 | SpassageQ | Spass, Inc. | 2023-06-15 | Traditional | PDF ↗ |
| K213423 | T3 Platform software | Etiometry, Inc. | 2023-01-06 | Traditional | PDF ↗ |
| K183282 | Biovitals Analytics Engine | Biofourmis Singapore Pte., Ltd. | 2019-08-15 | Traditional | PDF ↗ |
| K152258 | T3 Software | Etiometry, Inc. | 2016-03-31 | Traditional | PDF ↗ |
| K142512 | Personalized Physiology Analytics Engine software | Vgbio, Inc (Dba Physiq) | 2015-06-11 | Traditional | PDF ↗ |
| K843905 | TRAUMA CARE EVALUATION | Quantitative | 1985-09-26 | Traditional | PDF ↗ |
Product code PLB · Class II · Cardiovascular. Data: openFDA.