RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER— 510(k) K885328

Name: FDA 510(k) clearance K885328
Creator: U.S. Food and Drug Administration
Published: 1989-03-22

Substantially Equivalent

Telediagnostic Systems, Inc.

FDA 510(k) clearance K885328 for RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER, Substantially Equivalent on 1989-03-22. 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: 1988-12-28
Decision date: 1989-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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