Skintact
FDA 510(k) K024264 · Leonhard Lang Co.
510(k) numberK024264
Submission
- Device name
- Skintact
- Applicant
- Leonhard Lang Co.
Stillwater, MN, US - Received
- December 23, 2002
- Decision date
- January 16, 2003
- 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
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| K100315 | 12 Lead GloveDRX · Special | I Needmd, Inc. | 04/23/2010SE |
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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 |
| K073104 | Skintact and Various Other TradenamesDRX · Special | 11/16/2007SE |
| 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 |
Questions and answers
When was Skintact cleared by the FDA?
Skintact (K024264) received a 510(k) decision of Substantially Equivalent on January 16, 2003, 24 days after the submission was received.
What is the product code of K024264?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.