Cleared Traditional

NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001

K934368 · Nk Biotechnical Engineering Co. · Neurology
Aug 1994
Decision
338d
Days
Class 1
Risk

About This 510(k) Submission

K934368 is an FDA 510(k) clearance for the NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001, a Device, Vibration Threshold Measurement (Class I — General Controls, product code LLN), submitted by Nk Biotechnical Engineering Co. (Minneapolis, US). The FDA issued a Cleared decision on August 11, 1994, 338 days after receiving the submission on September 7, 1993. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1200.

Submission Details

510(k) Number K934368 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 1993
Decision Date August 11, 1994
Days to Decision 338 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code LLN — Device, Vibration Threshold Measurement
Device Class Class I — General Controls
CFR Regulation 21 CFR 882.1200

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