510(k) K900161

A-SCAN ROLL-AROUND STAND by Jedmed Instrument Co. — Product Code HMG

K900161 is an FDA 510(k) premarket notification submitted by Jedmed Instrument Co. for the device "A-SCAN ROLL-AROUND STAND". The FDA issued a decision of Substantially Equivalent on February 16, 1990. The device falls under product code HMG (Stand, Instrument, Ophthalmic, Non-Powered), a Class I device regulated under 21 CFR 886.1860. Jedmed Instrument Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1990
Date Received
January 12, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stand, Instrument, Ophthalmic, Non-Powered
Device Class
Class I
Regulation Number
886.1860
Review Panel
OP
Submission Type