510(k) K143094
- Device
- QuantaFlo
- Applicant
- SEMLER SCIENTIFIC, INC.
- 510(k) number
- K143094
- Product code
- JOM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-03-05
- Date received
- 2014-10-28
- Regulation
- 870.2780
- Classification name
- Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BOB MCRAE
- Address
- 2330 NW Everett St. Portland OR US 97210 97210
FDA Registration Numbers#
- 2134492
- 3012528160
- 3008717264
- 9610816
- 3014541700
- 3020115
- 3009690509
- 3013783488
- 3007048291
- 3011861727
- 3016701404
- 3009077524
- 3008577991
- 3019130
- 3008791915
- 3010536822
- 2000010846
- 1218950
- 1000589001
- 3006146787
- 9681377
- 3012302888
- 2245574
- 3000126629
- 3008514120
Source Documents#
Other 510(k) Records For Product Code JOM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220527 | PADnet Xpress | Collaborative Care Diagnostics, LLC, D.B.A. Biomedix | 2022-10-20 |
| K213730 | MESI mTABLET TBI diagnostic system, MESI mTABLET TBI | Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. | 2022-04-21 |
| K200567 | ASI Plethysmogrpah Analyzer | Arterial Stiffness, Inc. | 2021-02-26 |
| K201046 | Automated ankle brachial pressure index measuring device, MESI mTABLET system | Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. | 2020-12-11 |
| K191266 | VitalScan ANS | Medeia, Inc. | 2020-01-15 |
| K172655 | Automated ankle brachial pressure index measuring device | Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. | 2018-01-11 |
| K173696 | TBL-ABI System | Ld Technology, LLC | 2017-12-19 |
| K143152 | TM-ABI system | Ld Technology, LLC | 2015-07-22 |
| K123921 | BODYTRONIC 200 | Bauerfeind AG | 2013-04-26 |
| K121108 | DOPPLEX ABILITY | Huntleigh Healthcare | 2013-01-03 |
| K122281 | PADNET 2.0 | Biomedix, Inc. | 2012-08-29 |
| K110374 | MAX PULSE SYSTEM | Medicore Co., Ltd. | 2011-06-13 |
| K101983 | CRITICAL CARE ASSESSMENT | Critical Patient Care, Inc. | 2010-09-21 |
| K093192 | FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE | Advanced Vascular Dynamics | 2010-02-12 |
| K083735 | ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS | Medtechs, LLC | 2009-02-18 |
Legacy Summary#
summary
FDA Review#
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