510(k) K853479

SKYTRON ELITE 300 SURGERY TABLE by Skytron, Div. the Kmw Group, Inc. — Product Code FWW

K853479 is an FDA 510(k) premarket notification submitted by Skytron, Div. the Kmw Group, Inc. for the device "SKYTRON ELITE 300 SURGERY TABLE". The FDA issued a decision of Substantially Equivalent on September 5, 1985. The device falls under product code FWW (Table, Operating-Room, Pneumatic), a Class I device regulated under 21 CFR 878.4960. Skytron, Div. the Kmw Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1985
Date Received
August 20, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Operating-Room, Pneumatic
Device Class
Class I
Regulation Number
878.4960
Review Panel
SU
Submission Type