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510(k) K972810

OPT80 THE TRANSPORTABLE (OPT80) by O.P.T. USA, Inc. — Product Code FQO

K972810 is an FDA 510(k) premarket notification submitted by O.P.T. USA, Inc. for the device "OPT80 THE TRANSPORTABLE (OPT80)". The FDA issued a decision of Substantially Equivalent on August 26, 1997. The device falls under product code FQO (Table, Operating-Room, Ac-Powered), a Class I device regulated under 21 CFR 878.4960.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1997
Date Received
July 28, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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FDA data resources