HLT · Class II · 21 CFR 886.1640

FDA Product Code HLT: Preamplifier, Ac-powered, Ophthalmic

Leading manufacturers include Chalgren Enterprises, Inc..

4
Total
4
Cleared
253d
Avg days
1978
Since

FDA 510(k) Cleared Preamplifier, Ac-powered, Ophthalmic Devices (Product Code HLT)

4 devices
1–4 of 4
Cleared Dec 07, 1994
DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING
K924277
Chalgren Enterprises, Inc.
Ophthalmic · 834d

About Product Code HLT - Regulatory Context