510(k) K842649

BATH TUB TRANSFER CHAIR by Guardian Products Co., Inc. — Product Code IKN

K842649 is an FDA 510(k) premarket notification submitted by Guardian Products Co., Inc. for the device "BATH TUB TRANSFER CHAIR". The FDA issued a decision of Substantially Equivalent on August 10, 1984. The device falls under product code IKN (Electromyograph, Diagnostic), a Class II device regulated under 21 CFR 890.1375. Guardian Products Co., Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1984
Date Received
July 10, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electromyograph, Diagnostic
Device Class
Class II
Regulation Number
890.1375
Review Panel
NE
Submission Type