Product code HLW

Device name: Preamplifier, Battery-Powered, Ophthalmic
Medical specialty: Ophthalmic
Device class: 2
Regulation number: 886.1640
Review panel: OP
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K900098	MONOPOLAR NEEDLE ELECTRODE	Oculinum, Inc.	1990-02-09
K900279	OCULINUM INJECTION AMPLIFIER	Oculinum, Inc.	1990-02-09
K854793	MONOPOLAR INJECTION NEEDLE ELECTRODE	Oculinum, Inc.	1986-02-18