Cleared Traditional

K952966 - CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM (FDA 510(k) Clearance)

K952966 · Nidek Medical Products, Inc. · Anesthesiology device
May 1996
Decision
315d
Days
Class 2
Risk

K952966 is an FDA 510(k) clearance for the CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM. This device is classified as a Ventilator, Non-continuous (respirator) (Class II - Special Controls, product code BZD).

Submitted by Nidek Medical Products, Inc. (Birmingham, US). The FDA issued a Cleared decision on May 7, 1996, 315 days after receiving the submission on June 27, 1995.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K952966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1995
Decision Date May 07, 1996
Days to Decision 315 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BZD - Ventilator, Non-continuous (respirator)
Device Class Class II - Special Controls
CFR Regulation 21 CFR 868.5905