SKINTACT ECG ELECTRODE
FDA 510(k) clearance K040249 · decided 2004-02-24
Clearance details
- K-number
- K040249
- Device name
- SKINTACT ECG ELECTRODE
- Applicant
- Leonhard Lang GmbH
- Decision
- Substantially Equivalent
- Date received
- 2004-02-03
- Decision date
- 2004-02-24
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- DRX
- Device class
- 2
- Regulation number
- 870.2360
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Stillwater, MN, US
- Third-party review
- No
- Expedited review
- No
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| AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X (K100129) | Ambu A/S | 2010-06-11 |
| INTCO TAB ELECTRODE (K093327) | Shanghai Intco Electrode Manufacturing Co., Ltd. | 2010-05-10 |
| 12 LEAD GLOVE (K100315) | I Needmd, Inc. | 2010-04-23 |
| NEONATAL ECG ELECTRODE, M203KEN (K092744) | R & D Medical Products, Inc. | 2009-12-10 |
| DISPOSAL ECG ELECTRODES, MODEL EASYRODE (K092389) | Suzuken Co., Ltd. | 2009-10-13 |
| QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH (K090496) | Cardiac Lead Technologies, Inc. | 2009-09-01 |
| SKINTACT AND VARIOUS OTHER TRADENAMES (K092291) | Leonhard Lang GmbH | 2009-08-21 |
Recalls involving this device
No recalls on record reference this clearance.