K833592Substantially Equivalent
X-Beam Film 3Tc
Amorient Ent., Mchenry IL / Traditional, Substantially Equivalent
K833592 is the FDA 510(k) clearance record for X-BEAM FILM 3TC, cleared for Amorient Ent. on . FDA records list one 510(k) clearance for Amorient Ent. As of , FDA records show no recalls naming K833592.
Clearance record
- Decision date
- Received
- (76 days to decision)
- Review panel
- Unknown
- Applicant
- Amorient Ent. 803 N. Front St. Suite 3, Mchenry IL
- Third party review
- No
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
