Cleared Traditional

K832950 - SCIENTRONICS 10K EYE MAGNET
(FDA 510(k) Clearance)

K832950 · Scientific Manufacturer · Ophthalmic device

Oct 1983

Decision

49d

Days

Class 2

Risk

K832950 is an FDA 510(k) clearance for the SCIENTRONICS 10K EYE MAGNET. This device is classified as a Magnet, Ac-powered (Class II - Special Controls, product code HPO).

Submitted by Scientific Manufacturer (Walker, US). The FDA issued a Cleared decision on October 19, 1983, 49 days after receiving the submission on August 31, 1983.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4440.

Submission Details

510(k) Number	K832950 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 31, 1983
Decision Date	October 19, 1983
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—