Cleared Traditional

DISPOSABLE, HYPERBARIC OXYGEN CHAMBER

K840817 · Hospitak, Inc. · General & Plastic Surgery

Apr 1984

Decision

61d

Days

Class 2

Risk

About This 510(k) Submission

K840817 is an FDA 510(k) clearance for the DISPOSABLE, HYPERBARIC OXYGEN CHAMBER, a Chamber, Oxygen, Topical, Extremity (Class II — Special Controls, product code KPJ), submitted by Hospitak, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 25, 1984, 61 days after receiving the submission on February 24, 1984. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5650.

Submission Details

510(k) Number	K840817 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 24, 1984
Decision Date	April 25, 1984
Days to Decision	61 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—