510(k) K992370

AMPLAID A724 AND A728 by Amplifon S.P.A. — Product Code ETY

K992370 is an FDA 510(k) premarket notification submitted by Amplifon S.P.A. for the device "AMPLAID A724 AND A728". The FDA issued a decision of Substantially Equivalent on September 20, 1999. The device falls under product code ETY (Tester, Auditory Impedance), a Class II device regulated under 21 CFR 874.1090. Amplifon S.P.A. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1999
Date Received
July 15, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Auditory Impedance
Device Class
Class II
Regulation Number
874.1090
Review Panel
EN
Submission Type