FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇹 Austria
SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES
K Number: K982521
·
Decision Oct 26, 1999
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
2
Review Days
463
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 ECG ELECTRODES, S&W ECG ELECTRODES
- K Number
- K982521
- 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 Co.
- Date Received
- July 20, 1998
- Decision Date
- October 26, 1999
- Product Code
- DRX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
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 Co.
| K Number | Device Name | ||
|---|---|---|---|
| K024264 | SKINTACT | Jan 16, 2003 | Substantially Equivalent |