LIFESCOPE 6 OEC-6102— 510(k) K841501
Substantially EquivalentNihon Kohden America, Inc.
FDA 510(k) clearance K841501 for LIFESCOPE 6 OEC-6102, Substantially Equivalent on 1984-08-28. Applicant: Nihon Kohden America, Inc.. Device class: 2.
Clearance details
- Applicant
- Nihon Kohden America, Inc.
- Product code
- Code DRT
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Foothill, CA, US
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Adverse events under product code DRT
product code DRT- Death
- 4
- Total
- 4
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.