Cleared Traditional

K041823 - PIONEER U121 SERIES CPAP (FDA 510(k) Clearance)

K041823 · Merits Health Products Co., Ltd. · Anesthesiology device

May 2005

Decision

308d

Days

Class 2

Risk

K041823 is an FDA 510(k) clearance for the PIONEER U121 SERIES CPAP. This device is classified as a Ventilator, Non-continuous (respirator) (Class II - Special Controls, product code BZD).

Submitted by Merits Health Products Co., Ltd. (Taichung, TW). The FDA issued a Cleared decision on May 10, 2005, 308 days after receiving the submission on July 6, 2004.

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

Submission Details

510(k) Number	K041823 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 06, 2004
Decision Date	May 10, 2005
Days to Decision	308 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF