FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT.
K Number: K911990
·
Decision Jun 21, 1991
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
4
Review Days
46
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
- ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT.
- K Number
- K911990
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Somnitec, Inc.
- Date Received
- May 6, 1991
- Decision Date
- June 21, 1991
- 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