510(k) K952289

WELCH ALLYN FIBER OPTIC HEADLIGNT by Welch Allyn, Inc. — Product Code HPQ

K952289 is an FDA 510(k) premarket notification submitted by Welch Allyn, Inc. for the device "WELCH ALLYN FIBER OPTIC HEADLIGNT". The FDA issued a decision of Substantially Equivalent on July 14, 1995. The device falls under product code HPQ (Headlamp, Operating, Ac-Powered), a Class II device regulated under 21 CFR 886.4335. Welch Allyn, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1995
Date Received
May 16, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Headlamp, Operating, Ac-Powered
Device Class
Class II
Regulation Number
886.4335
Review Panel
OP
Submission Type