Personalized Physiology Analytics Engine software
FDA 510(k) K142512 · Vgbio, Inc (Dba Physiq)
510(k) numberK142512
Submission
- Device name
- Personalized Physiology Analytics Engine software
- Applicant
- Vgbio, Inc (Dba Physiq)
Naperville, IL, US - Received
- September 8, 2014
- Decision date
- June 11, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PLB – Multivariate Vital Signs Index
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs.
Other 510(k)s with product code PLB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240756 | Aitrics-VcPLB · Traditional | Aitrics Co., Ltd. | 07/23/2024SE |
| K240558 | NavoycdsPLB · Traditional | Algodx AB | 07/22/2024SE |
| K230386 | SpassageQPLB · Traditional | Spass, Inc. | 06/15/2023SE |
| K213423 | T3 Platform softwarePLB · Traditional | Etiometry, Inc. | 01/06/2023SE |
| K183282 | Biovitals Analytics EnginePLB · Traditional | Biofourmis Singapore Pte., Ltd. | 08/15/2019SE |
| K152258 | T3 SoftwarePLB · Traditional | Etiometry, Inc. | 03/31/2016SE |
| K843905 | Trauma Care EvaluationPLB · Traditional | Quantitative | 09/26/1985SE |
Questions and answers
When was Personalized Physiology Analytics Engine software cleared by the FDA?
Personalized Physiology Analytics Engine software (K142512) received a 510(k) decision of Substantially Equivalent on June 11, 2015, 276 days after the submission was received.
What is the product code of K142512?
The FDA product code is PLB – Multivariate Vital Signs Index, a Class II (moderate risk) device regulated under 21 CFR 870.2300.