Cleared Traditional

MAXAIR SURGICAL HELMET SYSTEM

K040485 · Bio-Medical Devices, Inc. · General Hospital
Oct 2004
Decision
236d
Days
Class 2
Risk

About This 510(k) Submission

K040485 is an FDA 510(k) clearance for the MAXAIR SURGICAL HELMET SYSTEM, a Gown, Surgical (Class II — Special Controls, product code FYA), submitted by Bio-Medical Devices, Inc. (Irvine, US). The FDA issued a Cleared decision on October 18, 2004, 236 days after receiving the submission on February 25, 2004. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K040485 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 2004
Decision Date October 18, 2004
Days to Decision 236 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FYA — Gown, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

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