AP-4000, AIR PULSE SENSORY STIMULATOR— 510(k) K964815

Name: FDA 510(k) clearance K964815
Creator: U.S. Food and Drug Administration
Published: 1997-09-04

Substantially Equivalent

Pentax Precision Instrument Corp.

FDA 510(k) clearance K964815 for AP-4000, AIR PULSE SENSORY STIMULATOR, Substantially Equivalent on 1997-09-04. Applicant: Pentax Precision Instrument Corp.. Device class: 1.

Clearance details

Applicant: Pentax Precision Instrument Corp.
Product code: Code LLN
Device class: Class 1
Regulation: 21 CFR 882.1200
Advisory panel: Neurology
Date received: 1996-11-29
Decision date: 1997-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miramar, FL, US

Download summary PDF View on FDA.gov ↗

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