ORBIOGRAPH— 510(k) K781543

Substantially Equivalent

Sonometrics Systems, Inc.

FDA 510(k) clearance K781543 for ORBIOGRAPH, Substantially Equivalent on 1978-10-24. Applicant: Sonometrics Systems, Inc.. Device class: 2.

Clearance details

Applicant: Sonometrics Systems, Inc.
Product code: Code HLT
Device class: Class 2
Regulation: 21 CFR 886.1640
Advisory panel: Ophthalmic
Date received: 1978-09-08
Decision date: 1978-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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