510(k) K914303

TARGET(TM)-HOG by V-Tech, Inc. — Product Code JHI

K914303 is an FDA 510(k) premarket notification submitted by V-Tech, Inc. for the device "TARGET(TM)-HOG". The FDA issued a decision of Substantially Equivalent on October 11, 1991. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. V-Tech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 1991
Date Received
September 25, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Visual, Pregnancy Hcg, Prescription Use
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type