FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SKINTACT ECG ELECTRODE
K Number: K023503
·
Decision Nov 14, 2002
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
17
Review Days
27
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Basic Information
- Device Name
- SKINTACT ECG ELECTRODE
- K Number
- K023503
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Leonhard Lang GmbH
- Date Received
- October 18, 2002
- Decision Date
- November 14, 2002
- Product Code
- DRX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | FDA class 2 | Cardiovascular |
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Other Clearances by Leonhard Lang GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K142803 | Skintact, various other tradenames | Dec 2, 2014 | Substantially Equivalent |
| K140500 | SKINTACT | Jul 29, 2014 | Substantially Equivalent |
| K140340 | SKINTACT | May 21, 2014 | Substantially Equivalent |
| K103186 | SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES | Feb 8, 2011 | Substantially Equivalent |
| K092291 | SKINTACT AND VARIOUS OTHER TRADENAMES | Aug 21, 2009 | Substantially Equivalent |
| K081371 | SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL | Sep 24, 2008 | Substantially Equivalent |
| K080106 | SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE | Feb 1, 2008 | Substantially Equivalent |
| K073104 | SKINTACT AND VARIOUS OTHER TRADENAMES | Nov 16, 2007 | Substantially Equivalent |
| K072233 | SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS | Oct 5, 2007 | Substantially Equivalent |
| K063161 | SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL | Nov 21, 2006 | Substantially Equivalent |