510(k) K090180
- Device
- TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE
- Applicant
- VERMED, INC.
- 510(k) number
- K090180
- Product code
- DRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-06-17
- Date received
- 2009-01-23
- Regulation
- 870.2360
- Classification name
- Electrode, Electrocardiograph
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARC FILLION
- Address
- 9 Lovell Dr. Bellows Falls VT US 05101 05101
FDA Registration Numbers#
- 3014982325
- 9681860
- 3008851924
- 3020977186
- 3009171251
- 9611295
- 3016096058
- 2031094
- 3010419931
- 3013188547
- 3036470679
- 3013681758
- 1423662
- 3020460367
- 3022568093
- 2438852
- 9610691
- 3011088743
- 3010838917
- 1625392
- 3013684844
- 3013791928
- 3007748793
- 1921846
- 3023272766
- 3007734888
- 3010576710
- 3016678045
- 3013517171
- 1423537
- 9613418
- 3006897996
- 3000268902
- 3004762958
- 3012606445
- 3003074886
- 3029901632
- 3007305485
- 1531159
- 1223925
- 3013508647
- 9680794
- 2133542
- 3016904853
- 3003072803
- 3015541720
- 3011307234
- 3042888450
- 3005273623
- 2025917
- 3008496560
- 3008773647
- 3014111150
- 3043479346
- 3010131466
- 3004040397
- 3007184699
- 3030733800
- 3042272797
- 3009883402
- 3014236293
- 3041276591
- 8022257
- 3011391433
- 3011237770
- 3014579161
- 3030626857
- 3038614698
- 9681465
- 3018044766
- 9610816
- 3000126629
- 1221108
- 3005327291
- 3006891611
- 3012027770
- 1043214
- 3008114669
- 1220908
- 1218950
Source Documents#
Other 510(k) Records For Product Code DRX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171244 | Physiotrace | Nimbleheart, Inc. | 2017-08-23 |
| K140096 | HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE | Hmicro, Inc. | 2014-07-24 |
| 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 |
| 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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