510(k) K861747

KEELER FIBEROPTIC HEADLAMP by Keeler Instruments, Inc. — Product Code HPQ

K861747 is an FDA 510(k) premarket notification submitted by Keeler Instruments, Inc. for the device "KEELER FIBEROPTIC HEADLAMP". The FDA issued a decision of Substantially Equivalent on August 21, 1986. The device falls under product code HPQ (Headlamp, Operating, Ac-Powered), a Class II device regulated under 21 CFR 886.4335. Keeler Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1986
Date Received
May 6, 1986
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