ACU220 Cryo Unit

FDA 510(k) K841294 · Keller Instruments, Inc.

Substantially Equivalent

510(k) numberK841294

Submission

Device name
ACU220 Cryo Unit
Applicant
Keller Instruments, Inc.
Walker, MI, US
Received
March 29, 1984
Decision date
August 15, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HQA – Unit, Cryotherapy, Ophthalmic
Device class
Class II (moderate risk)
Regulation
21 CFR 886.4170
Specialty
Ophthalmic

Other 510(k)s with product code HQA

510(k)DeviceApplicantDecision
K854422Series 25 Slimline Cryo ProbesHQA · Traditional Keeler Instruments, Inc.12/30/1985SE
K854411Keeler-Compact Cryo SystemHQA · Traditional Keeler Instruments, Inc.12/30/1985SE
K823835Spembly 140 Cryosystem Probes & TipsHQA · Traditional Keller Instruments, Inc.01/17/1983SE

More from Keller Instruments, Inc.

510(k)DeviceDecision
K854541Tip Off ForcepsGEN · Traditional 12/17/1985SE
K841293Panoramic Loupes - VariousHLT · Traditional 05/09/1984SE
K841292Spectacle Indirect OphthalmoscopeHLJ · Traditional 05/09/1984SE
K823835Spembly 140 Cryosystem Probes & TipsHQA · Traditional 01/17/1983SE

Questions and answers

When was ACU220 Cryo Unit cleared by the FDA?

ACU220 Cryo Unit (K841294) received a 510(k) decision of Substantially Equivalent on August 15, 1984, 139 days after the submission was received.

What is the product code of K841294?

The FDA product code is HQA – Unit, Cryotherapy, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4170.