FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SKINTACT
K Number: K023920
·
Decision Jan 16, 2003
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
17
Review Days
52
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SKINTACT
- K Number
- K023920
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Leonhard Lang GmbH
- Date Received
- November 25, 2002
- Decision Date
- January 16, 2003
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRX), ordered by most recent decision date.
Physiotrace
FDA 510(k)
FDA Class 2
·Cardiovascular
HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOMODULE 3-M1
FDA 510(k)
FDA Class 2
·Cardiovascular
CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES
FDA 510(k)
FDA Class 2
·Cardiovascular
IP-SET
FDA 510(k)
FDA Class 2
·Cardiovascular
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
FDA 510(k)
FDA Class 2
·Cardiovascular
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 |