MESI mTABLET TBI diagnostic system, MESI mTABLET TBI
FDA 510(k) K213730 · Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.
510(k) numberK213730
Submission
- Device name
- MESI mTABLET TBI diagnostic system, MESI mTABLET TBI
- Applicant
- Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.
Ljubljana, SI - Received
- November 26, 2021
- Decision date
- April 21, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JOM – Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2780
- Specialty
- Cardiovascular
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| K220527 | PADnet XpressJOM · Special | Collaborative Care Diagnostics, LLC, D.B.A.… | 10/20/2022SE |
| K200567 | ASI Plethysmogrpah AnalyzerJOM · Traditional | Arterial Stiffness, Inc. | 02/26/2021SE |
| K201046 | Automated ankle brachial pressure index measuring device, MESI mTABLET systemJOM · Traditional | Mesi D.O.O.; Mesi, Development of Medical… | 12/11/2020SE |
| K191266 | VitalScan ANSJOM · Traditional | Medeia, Inc. | 01/15/2020SE |
| K172655 | Automated ankle brachial pressure index measuring deviceJOM · Traditional | Mesi D.O.O.; Mesi, Development of Medical… | 01/11/2018SE |
| K173696 | TBL-ABI SystemJOM · Special | Ld Technology, LLC | 12/19/2017SE |
| K143152 | TM-ABI systemJOM · Traditional | Ld Technology, LLC | 07/22/2015SE |
| K143094 | QuantaFloJOM · Traditional | Semler Scientific, Inc. | 03/05/2015SE |
| K123921 | Bodytronic 200JOM · Traditional | Bauerfeind AG | 04/26/2013SE |
| K121108 | Dopplex AbilityJOM · Traditional | Huntleigh Healthcare | 01/03/2013SE |
More from Huntleigh Healthcare
| 510(k) | Device | Decision |
|---|---|---|
| K223670 | MESI mTablet ECG Diagnostic System, MESI mTablet ECGDPS · Traditional | 07/28/2023SE |
Questions and answers
When was MESI mTABLET TBI diagnostic system, MESI mTABLET TBI cleared by the FDA?
MESI mTABLET TBI diagnostic system, MESI mTABLET TBI (K213730) received a 510(k) decision of Substantially Equivalent on April 21, 2022, 146 days after the submission was received.
What is the product code of K213730?
The FDA product code is JOM – Plethysmograph, Photoelectric, Pneumatic Or Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 870.2780.