510(k) K182030
- Device
- Faros Mobile
- Applicant
- Bittium Biosignals Ltd.
- 510(k) number
- K182030
- Product code
- MLO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-11-08
- Date received
- 2018-07-30
- Regulation
- 870.2800
- Classification name
- Electrocardiograph, Ambulatory, With Analysis Algorithm
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Taneli Vaaraniemi
- Address
- Pioneerinkatu 6 Kuopio FI FI-70800 FI-70800
FDA Registration Numbers#
- 3021988268
- 3006948155
- 3010082909
- 3007184699
- 3012528160
- 3016406615
- 3012027770
- 3008717264
- 9681548
- 3006087789
- 3017840980
- 3014522540
- 3008799846
- 1000425315
- 3016701404
- 1316463
- 1063925
- 3016618143
- 3005737664
- 3010381606
- 3010390468
- 3023146633
- 1218950
- 1126271
- 1033601
- 3011937459
- 3012302888
- 3008977358
- 3000126629
- 3032536454
- 3006979678
Source Documents#
Other 510(k) Records For Product Code MLO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241890 | Philips Holter Analysis System | Philips Medizin Systeme Böblingen GmbH | 2025-03-21 |
| K240794 | Frontier X Plus | Fourth Frontier Technologies Pvt, Ltd. | 2024-11-08 |
| K200833 | RX-1 Rhythm Express Remote Cardiac Monitoring System | VivaQuant, Inc. | 2020-09-02 |
| K193177 | CER-S | Cardiocalm | 2020-08-26 |
| K140847 | CARDIOSPY ECG HOLTER SYSTEMS | Labtech Kft. | 2014-12-05 |
| K131897 | CV3000 HOLTER ANALYSIS SYSTEM | Vales & Hills Biomedical Tech. , Ltd. | 2013-11-26 |
| K130660 | AUDICOR CPAM WITH SDB (SINGLE SENSOR) | Inovise Medical, Inc. | 2013-10-11 |
| K120462 | AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION) | Inovise Medical, Inc. | 2012-09-20 |
| K111487 | NH-301 AMBULATORY ECG ANALYSIS SOFTWARE | Norav Medical Corp. | 2011-11-10 |
| K110569 | AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) | Inovise Medical, Inc. | 2011-10-24 |
| K101273 | DYNAMIC ECG SYSTEM MODEL TLC5000 | Contec Medical System Co., Ltd. | 2011-09-30 |
| K092853 | 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM | Galix Biomedical Instrumentation, Inc. | 2010-07-09 |
| K063339 | MEDICK MHM200 PERSONAL HEART MONITOR | Medick Healthcare , Ltd. | 2007-06-29 |
| K062088 | PREMIER 11 HOLTER | Diagnostic Monitoring Software | 2006-08-25 |
| K051730 | MATRIX HOLTER SYSTEM, MODEL M12 | Global Instrumentation, LLC | 2005-09-26 |
Legacy Summary#
summary
FDA Review#
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