510(k) K020003
- Device
- ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
- Applicant
- BIO PROTECH, INC.
- 510(k) number
- K020003
- Product code
- DRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-11-07
- Date received
- 2002-01-02
- 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
- JANNA P TUCKER
- Address
- 198 Ave. De La D'Emerald Sparks NV US 89434 89434
FDA Registration Numbers#
- 8022257
- 3013557562
- 2025917
- 3023164
- 3010131137
- 3013517171
- 3013783488
- 3013873578
- 3038988287
- 3013426279
- 3008773647
- 3029137407
- 3009555600
- 3014271754
- 3011391433
- 3007307487
- 1051786
- 2427500
- 3003674698
- 3010693883
- 3013681758
- 3005273623
- 3010882708
- 3013298431
- 3031887985
- 3008933393
- 9680794
- 3008851924
- 3014848734
- 3017450375
- 3000947648
- 3014982336
- 3015286931
- 3018783526
- 1219103
- 3043648109
- 1030451
- 3034669683
- 2183164
- 3007184699
- 3016618143
- 3001124136
- 1417592
- 2320762
- 2434982
- 2025066
- 3004040397
- 3015541720
- 8020045
- 3007048259
- 3005327291
- 9681860
- 9613910
- 3010419931
- 3042888450
- 3006891611
- 3014220748
- 2080225
- 3009883402
- 3022568093
- 3006636961
- 3011310592
- 3029901632
- 3030626857
- 3007734888
- 3036470679
- 3008617703
- 3004203820
- 3030733800
- 1218950
- 3010576710
- 3017425211
- 3012494290
- 3038181770
- 1043214
- 3043479346
- 3013508647
- 3045058049
- 3004903538
- 3014236293
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 |
| K090180 | TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE | Vermed, Inc. | 2009-06-17 |
| K083677 | PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 | Commwell , Ltd. | 2009-03-10 |
Legacy Summary#
summary
FDA Review#
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