510(k) K990031— NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES
Substantially EquivalentNihon Kohden America, Inc.
Clearance details
- Applicant
- Nihon Kohden America, Inc.
- Product code
- Code LOS
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.