510(k) K874251

WORTH 4 DOT TEST DISTANCE C/W MUSCLE LIGHT by Richmond Products, Inc. — Product Code HLP

K874251 is an FDA 510(k) premarket notification submitted by Richmond Products, Inc. for the device "WORTH 4 DOT TEST DISTANCE C/W MUSCLE LIGHT". The FDA issued a decision of Substantially Equivalent on January 11, 1988. The device falls under product code HLP (Target, Fusion And Stereoscopic), a Class I device regulated under 21 CFR 886.1880. Richmond Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1988
Date Received
October 19, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Target, Fusion And Stereoscopic
Device Class
Class I
Regulation Number
886.1880
Review Panel
OP
Submission Type