Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K842607Substantially Equivalent

Infant Apnea Bed Stimulator Aa-010

Alpha Medical Systems, Mchenry IL / Traditional, Substantially Equivalent

K842607 is the FDA 510(k) clearance record for INFANT APNEA BED STIMULATOR AA-010, cleared for Alpha Medical Systems on . FDA records list 2 510(k) clearances for Alpha Medical Systems, from to . As of , FDA records show no recalls naming K842607.

Clearance record

Decision date
Received
(70 days to decision)
Review panel
Unknown
Applicant
Alpha Medical Systems 803 N. Front St. Suite 3, Mchenry IL
Third party review
No