Cleared Traditional

K936187 - LSPI PRESSURE REGULATOR
(FDA 510(k) Clearance)

Jan 1994
Decision
35d
Days
Class 1
Risk

K936187 is an FDA 510(k) clearance for the LSPI PRESSURE REGULATOR. This device is classified as a Regulator, Pressure, Gas Cylinder (Class I - General Controls, product code CAN).

Submitted by Life Support Products, Inc. (Irvine, US). The FDA issued a Cleared decision on January 27, 1994, 35 days after receiving the submission on December 23, 1993.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2700.

Submission Details

510(k) Number K936187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1993
Decision Date January 27, 1994
Days to Decision 35 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAN — Regulator, Pressure, Gas Cylinder
Device Class Class I - General Controls
CFR Regulation 21 CFR 868.2700

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