510(k) K014044

MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT) by Notal Vision, Inc. — Product Code HOQ

K014044 is an FDA 510(k) premarket notification submitted by Notal Vision, Inc. for the device "MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT)". The FDA issued a decision of Substantially Equivalent on March 4, 2002. The device falls under product code HOQ (Grid, Amsler), a Class I device regulated under 21 CFR 886.1330. Notal Vision, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2002
Date Received
December 7, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Grid, Amsler
Device Class
Class I
Regulation Number
886.1330
Review Panel
OP
Submission Type