510(k) K941723

WELCH ALLYN GLAUCOMA DETECTOR by Welch Allyn, Inc. — Product Code HOO

K941723 is an FDA 510(k) premarket notification submitted by Welch Allyn, Inc. for the device "WELCH ALLYN GLAUCOMA DETECTOR". The FDA issued a decision of Substantially Equivalent on June 6, 1994. The device falls under product code HOO (Perimeter, Ac-Powered), a Class I device regulated under 21 CFR 886.1605. Welch Allyn, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1994
Date Received
April 7, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Perimeter, Ac-Powered
Device Class
Class I
Regulation Number
886.1605
Review Panel
OP
Submission Type