Skintact and Various Other Tradenames
FDA 510(k) K073104 · Leonhard Lang GmbH
510(k) numberK073104
Submission
- Device name
- Skintact and Various Other Tradenames
- Applicant
- Leonhard Lang GmbH
Stillwater, MN, US - Received
- November 2, 2007
- Decision date
- November 16, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRX – Electrode, Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2360
- Specialty
- Cardiovascular
Other 510(k)s with product code DRX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K171244 | PhysiotraceDRX · Traditional | Nimbleheart, Inc. | 08/23/2017SE |
| K140096 | Hmicro Wired C-Patch Electrode, Trade Name Subject to ChangeDRX · Traditional | Hmicro, Inc. | 07/24/2014SE |
| K123658 | Biomodule 3-M1DRX · Traditional | Zephyr Technology Corporation | 04/24/2013SE |
| K101576 | Centerridge Diagnostic ECG Electrode, Centerridge Monitoring ECG ElectrodesDRX · Traditional | Team Innovations, Inc. | 07/22/2010SE |
| K101685 | Ip-SetDRX · Traditional | Integral Process Sas | 07/01/2010SE |
| K100129 | Ambu Blue Sensor Neo, Ambu Blue Sensor Neo XDRX · Abbreviated | Ambu A/S | 06/11/2010SE |
| K093327 | Intco Tab ElectrodeDRX · Abbreviated | Shanghai Intco Electrode Manufacturing Co., Ltd. | 05/10/2010SE |
| K100315 | 12 Lead GloveDRX · Special | I Needmd, Inc. | 04/23/2010SE |
| K092744 | Neonatal ECG Electrode, M203KENDRX · Traditional | R & D Medical Products, Inc. | 12/10/2009SE |
| K092389 | Disposal ECG Electrodes, Model EasyrodeDRX · Traditional | Suzuken Co., Ltd. | 10/13/2009SE |
More from Suzuken Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K142803 | Skintact, various other tradenamesMKJ · Traditional | 12/02/2014SE |
| K140500 | SkintactGEI · Traditional | 07/29/2014SE |
| K140340 | SkintactGXY · Traditional | 05/21/2014SE |
| K103186 | Skintact Radiotransparent Multifunction ElectrodesMKJ · Traditional | 02/08/2011SE |
| K092291 | Skintact and Various Other TradenamesDRX · Special | 08/21/2009SE |
| K081371 | Skintact Pediatric Multifunction Electrodes with DH03 GelMKJ · Traditional | 09/24/2008SE |
| K080106 | Skintact Pre-Wired ECG Electrodes with Conductive AdhesiveDRX · Special | 02/01/2008SE |
| K072233 | Skintact Multifunctional Electrodes with DH02 Gel with Different Connectors Compatible…MKJ · Special | 10/05/2007SE |
| K063161 | Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 GelGEI · Special | 11/21/2006SE |
| K041883 | Skintact Multifunction Electrodes, Model DF 21MKJ · Traditional | 09/07/2004SE |
Questions and answers
When was Skintact and Various Other Tradenames cleared by the FDA?
Skintact and Various Other Tradenames (K073104) received a 510(k) decision of Substantially Equivalent on November 16, 2007, 14 days after the submission was received.
What is the product code of K073104?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.