Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K771431Substantially Equivalent

Artificial K-Nose Breathaid

Terumo America, Inc., Mchenry IL / Traditional, Substantially Equivalent

K771431 is the FDA 510(k) clearance record for ARTIFICIAL K-NOSE BREATHAID, cleared for Terumo America, Inc. on . FDA records list 31 510(k) clearances for Terumo America, Inc., from to . As of , FDA records show no recalls naming K771431.

Clearance record

Decision date
Received
(58 days to decision)
Review panel
Unknown
Applicant
Terumo America, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No