FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
TDK ECG ELECTRODE MEL-08-09 & -11
K Number: K854596
·
Decision May 7, 1986
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
147
Applicant Total
6
Review Days
170
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Basic Information
- Device Name
- TDK ECG ELECTRODE MEL-08-09 & -11
- K Number
- K854596
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2850
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Tdk Corp.
- Date Received
- November 18, 1985
- Decision Date
- May 7, 1986
- Product Code
- DRS
- 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 |
|---|---|---|---|
| DRS | Transducer, Blood-Pressure, Extravascular | FDA class 2 | Cardiovascular |
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Other Clearances by Tdk Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K883643 | TDK ECG ELECTRODE, MEL-10L | Nov 17, 1988 | Substantially Equivalent |
| K882904 | TDK ELECTRODE MEL-20-1, MEL-20-3, MEL-20-5 | Oct 5, 1988 | Substantially Equivalent |
| K870834 | TDK ECG ELECTRODE MEL-10 | Mar 23, 1987 | Substantially Equivalent |
| K863369 | MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES | Jan 6, 1987 | Substantially Equivalent |
| K833899 | TDK ECG ELECTRODE MEL-08 | Feb 10, 1984 | Substantially Equivalent |