510(k) K922572

321Q MINIMUM ENERGY TINNITUS SUPPRESSOR by Microbio-Medics, Inc. — Product Code KLW

K922572 is an FDA 510(k) premarket notification submitted by Microbio-Medics, Inc. for the device "321Q MINIMUM ENERGY TINNITUS SUPPRESSOR". The FDA issued a decision of Substantially Equivalent on November 2, 1992. The device falls under product code KLW (Masker, Tinnitus), a Class II device regulated under 21 CFR 874.3400. Microbio-Medics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1992
Date Received
June 1, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Masker, Tinnitus
Device Class
Class II
Regulation Number
874.3400
Review Panel
EN
Submission Type