Cleared Traditional

K841605 - BP TRAUMA AIR PANTS (FDA 510(k) Clearance)

K841605 · Bp Medical Systems, Inc. · Anesthesiology device

Jul 1984

Decision

78d

Days

Class 2

Risk

K841605 is an FDA 510(k) clearance for the BP TRAUMA AIR PANTS. This device is classified as a Trousers, Anti-shock (Class II - Special Controls, product code LHX).

Submitted by Bp Medical Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 6, 1984, 78 days after receiving the submission on April 19, 1984.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number	K841605 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 19, 1984
Decision Date	July 06, 1984
Days to Decision	78 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—