DELTATALKER WITH INFRARED— 510(k) K961306

Substantially Equivalent

Prentke Romich Co.

FDA 510(k) clearance K961306 for DELTATALKER WITH INFRARED, Substantially Equivalent on 1996-06-27. Applicant: Prentke Romich Co.. Device class: 2.

Clearance details

Applicant: Prentke Romich Co.
Product code: Code IQA
Device class: Class 2
Regulation: 21 CFR 890.3725
Advisory panel: Physical Medicine
Date received: 1996-04-04
Decision date: 1996-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wooster, OH, US

Download summary PDF View on FDA.gov ↗

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