LOGOS8821 1-CHANNEL DIRECT-WRITING ELECTROCARDIOGR— 510(k) K851662
Substantially EquivalentLogos Medical Co., Ltd.
FDA 510(k) clearance K851662 for LOGOS8821 1-CHANNEL DIRECT-WRITING ELECTROCARDIOGR, Substantially Equivalent on 1985-11-14. Applicant: Logos Medical Co., Ltd..
Clearance details
- Applicant
- Logos Medical Co., Ltd.
- Product code
- Code DPS
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tokyo, 113 Japan, JP
Adverse events under product code DPS
product code DPS- Death
- 7
- Total
- 7
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.