510(k) K140096
- Device
- HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE
- Applicant
- HMICRO, INC.
- 510(k) number
- K140096
- Product code
- DRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-07-24
- Date received
- 2014-01-14
- Regulation
- 870.2360
- Classification name
- Electrode, Electrocardiograph
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KIM TOMPKINS
- Address
- 4984 El Camino Real #200 Los Altos CA US 94022 94022
FDA Registration Numbers#
- 2133585
- 1423537
- 3004203820
- 9681860
- 3042888450
- 3007734888
- 3006636961
- 3003674698
- 1718791
- 1219103
- 3034669683
- 3014111150
- 3003074886
- 1423662
- 3009443693
- 3011310592
- 3015286931
- 3011088743
- 3013783488
- 1051786
- 3009883402
- 3031841433
- 1000425315
- 3006897996
- 3006227741
- 8022257
- 3010805941
- 3007305485
- 3011787398
- 3031887985
- 2183164
- 3011237770
- 3010576710
- 3003749270
- 3010583453
- 9613910
- 3006626283
- 3038614698
- 2438852
- 3020977186
- 2022388
- 3018783526
- 9611295
- 3008933393
- 3009171251
- 3007770159
- 3017425211
- 3043479346
- 3010693883
- 3000268902
- 3012027770
- 3013188547
- 3017567825
- 3004040397
- 9610816
- 8043459
- 3005327291
- 1063285
- 1833310
- 3014848734
- 3022298579
- 3023164
- 1921846
- 3016812424
- 3004903538
- 3013791928
- 3013627970
- 3010419931
- 9710582
- 3010131466
- 3013684844
- 1221108
- 3022568093
- 3006210673
- 3031233916
- 3011359729
- 3012606445
- 2427500
- 3030626857
Source Documents#
Other 510(k) Records For Product Code DRX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171244 | Physiotrace | Nimbleheart, Inc. | 2017-08-23 |
| K123658 | BIOMODULE 3-M1 | Zephyr Technology Corporation | 2013-04-24 |
| K101576 | CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES | Team Innovations, Inc. | 2010-07-22 |
| K101685 | IP-SET | Integral Process Sas | 2010-07-01 |
| K100129 | AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X | Ambu A/S | 2010-06-11 |
| K093327 | INTCO TAB ELECTRODE | Shanghai Intco Electrode Manufacturing Co., Ltd. | 2010-05-10 |
| K100315 | 12 LEAD GLOVE | I Needmd, Inc. | 2010-04-23 |
| K092744 | NEONATAL ECG ELECTRODE, M203KEN | R & D Medical Products, Inc. | 2009-12-10 |
| K092389 | DISPOSAL ECG ELECTRODES, MODEL EASYRODE | Suzuken Co., Ltd. | 2009-10-13 |
| K090496 | QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH | Cardiac Lead Technologies, Inc. | 2009-09-01 |
| K092291 | SKINTACT AND VARIOUS OTHER TRADENAMES | Leonhard Lang GmbH | 2009-08-21 |
| K091856 | CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES | Conmed Corporation | 2009-08-07 |
| K090180 | TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE | Vermed, Inc. | 2009-06-17 |
| K083677 | PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 | Commwell , Ltd. | 2009-03-10 |
| K083148 | TELECTRODE WET GEL ECG ELECTRODE | Bio Protech, Inc. | 2008-11-07 |
Legacy Summary#
summary
FDA Review#
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