S-10 TELEPHONIC POLYSOMNOGRAPH— 510(k) K874257

Name: FDA 510(k) clearance K874257
Creator: U.S. Food and Drug Administration
Published: 1987-12-11

Substantially Equivalent

Telediagnostic Systems, Inc.

FDA 510(k) clearance K874257 for S-10 TELEPHONIC POLYSOMNOGRAPH, Substantially Equivalent on 1987-12-11. Applicant: Telediagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Telediagnostic Systems, Inc.
Product code: Code GYE
Device class: Class 2
Regulation: 21 CFR 882.1855
Advisory panel: Neurology
Date received: 1987-10-20
Decision date: 1987-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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