BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90— 510(k) K040056
Substantially EquivalentBio-Detek, Inc.
FDA 510(k) clearance K040056 for BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90, Substantially Equivalent on 2004-04-09. Applicant: Bio-Detek, Inc.. Device class: 3.
Clearance details
- Applicant
- Bio-Detek, Inc.
- Product code
- Code MKJ
- Device class
- Class 3
- Regulation
- 21 CFR 870.5310
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pawtucket, RI, US
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Adverse events under product code MKJ
product code MKJ- Death
- 961
- Injury
- 1,070
- Malfunction
- 90,719
- Other
- 8
- Total
- 92,758
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.