Automated ankle brachial pressure index measuring device
FDA 510(k) K172655 · Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.
510(k) numberK172655
Submission
- Device name
- Automated ankle brachial pressure index measuring device
- Applicant
- Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.
Ljubljana, SI - Received
- September 5, 2017
- Decision date
- January 11, 2018
- 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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| K143094 | QuantaFloJOM · Traditional | Semler Scientific, Inc. | 03/05/2015SE |
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More from Huntleigh Healthcare
| 510(k) | Device | Decision |
|---|---|---|
| K201046 | Automated ankle brachial pressure index measuring device, MESI mTABLET systemJOM · Traditional | 12/11/2020SE |
Questions and answers
When was Automated ankle brachial pressure index measuring device cleared by the FDA?
Automated ankle brachial pressure index measuring device (K172655) received a 510(k) decision of Substantially Equivalent on January 11, 2018, 128 days after the submission was received.
What is the product code of K172655?
The FDA product code is JOM – Plethysmograph, Photoelectric, Pneumatic Or Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 870.2780.