Cleared Traditional

K781543 - ORBIOGRAPH
(FDA 510(k) Clearance)

K781543 · Sonometrics Systems, Inc. · Ophthalmic device

Oct 1978

Decision

46d

Days

Class 2

Risk

K781543 is an FDA 510(k) clearance for the ORBIOGRAPH. This device is classified as a Preamplifier, Ac-powered, Ophthalmic (Class II - Special Controls, product code HLT).

Submitted by Sonometrics Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 24, 1978, 46 days after receiving the submission on September 8, 1978.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1640.

Submission Details

510(k) Number	K781543 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 08, 1978
Decision Date	October 24, 1978
Days to Decision	46 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—