510(k) K933220

SELECTOR SL 01 by Futuremed Div. of Future Impex Corp. — Product Code EWO

K933220 is an FDA 510(k) premarket notification submitted by Futuremed Div. of Future Impex Corp. for the device "SELECTOR SL 01". The FDA issued a decision of Substantially Equivalent on November 24, 1993. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Futuremed Div. of Future Impex Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1993
Date Received
July 1, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Audiometer
Device Class
Class II
Regulation Number
874.1050
Review Panel
EN
Submission Type