510(k) K900472

SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI by Skytron, Div. the Kmw Group, Inc. — Product Code HBN

K900472 is an FDA 510(k) premarket notification submitted by Skytron, Div. the Kmw Group, Inc. for the device "SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI". The FDA issued a decision of Substantially Equivalent on September 4, 1990. The device falls under product code HBN (Chair, Neurosurgical), a Class I device regulated under 21 CFR 882.4125. 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 4, 1990
Date Received
January 31, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, Neurosurgical
Device Class
Class I
Regulation Number
882.4125
Review Panel
NE
Submission Type