510(k) K832997

EPA AUTOMATED INFUSION POLE by Miami Eye Technology, Inc. — Product Code HQC

K832997 is an FDA 510(k) premarket notification submitted by Miami Eye Technology, Inc. for the device "EPA AUTOMATED INFUSION POLE". The FDA issued a decision of Substantially Equivalent on October 4, 1983. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Miami Eye Technology, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1983
Date Received
September 2, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type