Dorc Intraocular Electromagnet

FDA 510(k) K830336 · Jedmed Instrument Co.

Substantially Equivalent

510(k) numberK830336

Submission

Device name
Dorc Intraocular Electromagnet
Applicant
Jedmed Instrument Co.
Mchenry, IL, US
Received
February 1, 1983
Decision date
March 9, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HPO – Magnet, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 886.4440
Specialty
Ophthalmic

Other 510(k)s with product code HPO

510(k)DeviceApplicantDecision
K854870Intraocular ElectromagnetHPO · Traditional Mira, Inc.02/19/1986SE
K832950Scientronics 10K Eye MagnetHPO · Traditional Scientific Manufacturer10/19/1983SE

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Questions and answers

When was Dorc Intraocular Electromagnet cleared by the FDA?

Dorc Intraocular Electromagnet (K830336) received a 510(k) decision of Substantially Equivalent on March 9, 1983, 36 days after the submission was received.

What is the product code of K830336?

The FDA product code is HPO – Magnet, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4440.