TDK ECG ELECTRODE MEL-08-09 & -11— 510(k) K854596
Substantially EquivalentTdk Corp.
FDA 510(k) clearance K854596 for TDK ECG ELECTRODE MEL-08-09 & -11, Substantially Equivalent on 1986-05-07. Applicant: Tdk Corp.. Device class: 2.
Clearance details
- Applicant
- Tdk Corp.
- Product code
- Code DRS
- Device class
- Class 2
- Regulation
- 21 CFR 870.2850
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- 272 01, Japan, JP
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- K163172 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
More clearances from Tdk Corp.
view allAdverse events under product code DRS
product code DRS- Death
- 8
- Malfunction
- 776
- Total
- 784
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.