FDA Device Registration & Listing · Santa Barbara, CA, US · Registration 3010536822
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| OLU | Normalizing Quantitative Electroencephalograph Software | Neurology | Class 2 | 882.1400 | 2025-02-05 |
| DPS | Electrocardiograph | Cardiovascular | Class 2 | 870.2340 | 2020-03-17 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | Cardiovascular | Class 2 | 870.2780 | 2020-03-17 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2020-03-17 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Cardiovascular | Class 2 | 870.1025 | 2020-09-17 |
| DSI | Detector And Alarm, Arrhythmia | Cardiovascular | Class 2 | 870.1025 | 2020-09-17 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2020-09-17 |
| DQA | Oximeter | Cardiovascular | Class 2 | 870.2700 | 2020-09-17 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Cardiovascular | Class 2 | 870.2300 | 2020-09-17 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | Cardiovascular | Class 2 | 870.2910 | 2020-09-17 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | Cardiovascular | Class 2 | 870.2780 | 2017-12-13 |
| GZO | Device, Galvanic Skin Response Measurement | Neurology | Class 2 | 882.1540 | 2015-12-24 |
| DPS | Electrocardiograph | Cardiovascular | Class 2 | 870.2340 | 2013-10-21 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | Cardiovascular | Class 2 | 870.2780 | 2013-10-21 |
| DPS | Electrocardiograph | Cardiovascular | Class 2 | 870.2340 | 2013-10-21 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K862544 | Suzuken Co., Ltd. | KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH | 1986-08-06 |
| K802368 | Marquette Electronics, Inc. | OPTION 301 PACEMAKER EVAL. MODULE MAC-1 | 1981-03-04 |
| K131503 | Edan Instruments, Inc. | SE-601 SERIES ELECTROCARDIOGRAPH | 2014-02-25 |
| K100940 | Andon Health Co, Ltd. | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 | 2010-06-29 |
| K251581 | Shenzhen Hingmed Medical Instrument Co., Ltd. | Wearable Ambulatory Blood Pressure Monitor (WBP-02A) | 2026-02-13 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0011-2022 | Welch Allyn Inc Mortara | 2 | ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers:
ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX,
ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX,
ELI280-DBA-AAFBD, ELI280-AAA-AAEBX, ELI280-BBA-ADFBD, ELI280-DDB-ACFAX,
MLBUR280-81X, ELI280-CAA-ACEBX, ELI280-AAA-AAHBX, ELI280-DDB-BDFAX,
ELI280-CAA-AAFBT, ELI280-DCD-ADFAD, ELI280-DDB-AACBX, ELI280-JXX-BDFAX,
ELI280-CAA-ADCBX, ELI280-BCB-AACBD, ELI280-LDX-ADFBX, ELI280-LDX-ADCBX,
ELI280-BDD-ADFAD, ELI280-BDB-AAFBD, ELI280-BDB-ACCAD, ELI280-BDB-ADFAD,
ELI280-LDX-ADFBD, ELI280-DDB-AAFBD, ELI280-DCB-ACFAD, ELI280-AAA-BAFAF,
MLBUR280-W1X, ELI280-DCB-AAABX, ELI280-AAA-ACAAX, ELI280-ADA-ABFBX,
ELI280-BCB-AAFBD, ELI280-BCB-AAFBX, ELI280-CEA-ADFBX, ELI280-CDA-ADABX,
ELI280-BDB-AAABX, ELI280-DDB-ACFBD, ELI280-DDB-BCFAX, ELI280-ADA-ADCAX,
ELI280-BDB-AACBX, ELI280-BCB-ACAAX, BUR280-81X, ELI280-DCB-AAFBG,
ELI280-BDB-AAFBT, ELI280-DCB-AAFAD, ELI280-CAA-ADFBX, ELI280-BDB-AAFBG,
ELI280-BDB-AAFBX, ELI280-DCA-ACAAX, ELI280-CAB-ACFBX, ELI280-ADA-ACFAX,
ELI280-CAA-AAFAT, ELI280-CAA-ACFBD, ELI280-CDA-ADCBX, ELI280-AAA-ADCBX,
ELI280-CAA-AAFBD, ELI280-DCB-BAFBT, ELI280-BBA-AAAAX, ELI280-BBA-AAFAD,
ELI280-DBA-AAFAD, ELI280-DCB-AAFBT, ELI280-DBA-ADFAX, ELI280-BBA-AAFBD,
MLBUR280-C1X, ELI280-BBA-ADFAX, ELI280-DDD-ADFAD, ELI280-DBA-AAFAX,
MLBUR280-W1D, ELI280-BCB-AACBX, ELI280-DCB-AACBD, ELI280-LDX-ADFBG,
ELI280-DCB-AACBX, ELI280-DBA-ADFBD, ELI280-DDB-AAFBG, ELI280-DBA-AAABD,
ELI280-DCB-AAFBX, ELI280-AAA-AAFBT, MLBUR280-C1D, ELI280-AAB-ADAAX,
ELI280-DDB-AAFBT, ELI280-CAA-AACBX, ELI280-CEB-ACFBX, ELI280-CAA-ABFAX,
ELI280-DDB-AAFBX, ELI280-DBA-AAAAX, ELI280-BCB-AAFBG, ELI280-BFA-ADCBX,
ELI280-LDX-ADABX, MLBUR280-81D, ELI280-BBA-ADFAD, ELI280-CAA-ADHAX,
ELI280-CEB-ACFBD, ELI280-AAB-ADCAD, ELI280-BDB-AACBD, ELI280-LDX-ADCBD,
ELI280-AAB-ACCBX, ELI280-AAA-ABFBX, ELI280-DAB-ADCAD, ELI280-AFB-ABCBX,
ELI280-DCB-AACAX, ELI280-DEB-ACFBD, ELI280-ADA-ACAAX, ELI280-AAB-ADFAD,
ELI280-DCB-AAFBD, ELI280-CAA-AAAAX, ELI280-BDB-ACCAX, ELI280-CAA-AAFBX,
ELI280-DDB-AAABX, ELI280-DCB-ACAAX, ELI280-CAA-ADFBD, ELI280-CBB-ACCBX,
ELI280-DDB-AACBD, ELI280-DDB-ACCAX, ELI280-A, ELI280-DFA-ADCBX,
ELI280-BCA-AAAAX, ELI280-DDB-AAAAX, ELI280-E, ELI280-C, ELI280-AAA-AAFBD,
ELI280-DFC-ADFAD, BUR280-C1X, ELI280-D, ELI280-BAA-ACCBD, ELI280-AAA-AAAAX, BUR280-W1X, ELI280-B, ELI280-BCB-AAABX, ELI280-BCB-AACAX, BUR280-W1D,
ELI280-F, ELI280-BCB-AAFAD, ELI280-BCB-BAFAX, BUR280-81D |
| Z-0041-2012 | Edan Instruments, Inc. 7/F, Yuehai Office Bldg. 1128 Nanyou Road Nanshan, Shenzhen Guangdong China | 2 | ECG Cable Part Number: 01.57.471017 for use with the SE-1 series, SE-3 series and SE-601 series Smart Electrocardiograph
ECG cable is an accessory of the following machines: SE-1 series, SE-3 series and SE-601 series electrocardiograph (ECG). The EDAN ECG is a diagnostic and prescription device only intended to be used in hospitals or healthcare facilities by qualified doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help medical professionals to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. ECG cable is packed in plastic bag, as an accessory putting together with ECG machine in the package box. |
| Z-0032-2025 | MEDLINE INDUSTRIES, LP Northfield | 2 | MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001 |
| Z-0033-2025 | MEDLINE INDUSTRIES, LP Northfield | 2 | MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U. |
| Z-0034-2025 | MEDLINE INDUSTRIES, LP Northfield | 2 | MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3010376446 | Firefly Neuroscience | Hod Ha-Sharon Central, IL |
| 3038189172 | BEE MEDIC GMBH | Bamberg Bavaria, DE |
| 3008008477 | G.TEC MEDICAL ENGINEERING GMBH | Graz Steiermark, AT |
| 3005713796 | G.TEC MEDICAL ENGINEERING GMBH | SCHIEDLBERG Oberosterreich, AT |
| 1531052 | BRAINMASTER TECHNOLOGIES, INC. | Bedford, OH, US |
3010536822 when referencing this establishment in official correspondence.