6 ms·
Yes, it's authorized for sale under an EUA, but it's not been proven safe and effective according to the normal 510k process. "Safe and Effective" is essential
by cameldrv 6y ago
Yes, it's authorized for sale under an EUA, but it's not been proven safe and effective according to the normal 510k process. "Safe and Effective" is essentially a legal term that means it's passed this process.