510(k) K102626

VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01 by Vega Technologies, Inc. — Product Code JCX

K102626 is an FDA 510(k) premarket notification submitted by Vega Technologies, Inc. for the device "VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01". The FDA issued a decision of Substantially Equivalent on November 12, 2010. The device falls under product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered), a Class II device regulated under 21 CFR 878.4780. Vega Technologies, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 2010
Date Received
September 13, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type