510(k) K832804

SESAM TABLE by Electro-Med Health Industries, Inc. — Product Code INQ

K832804 is an FDA 510(k) premarket notification submitted by Electro-Med Health Industries, Inc. for the device "SESAM TABLE". The FDA issued a decision of Substantially Equivalent on September 20, 1983. The device falls under product code INQ (Table, Powered), a Class I device regulated under 21 CFR 890.3760. Electro-Med Health Industries, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1983
Date Received
August 18, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Powered
Device Class
Class I
Regulation Number
890.3760
Review Panel
PM
Submission Type