Cleared Traditional

LSP MINILATOR

K860516 · Life Support Products, Inc. · Anesthesiology
Feb 1986
Decision
10d
Days
Class 1
Risk

About This 510(k) Submission

K860516 is an FDA 510(k) clearance for the LSP MINILATOR, a Flowmeter, Calibration, Gas (Class I — General Controls, product code BXY), submitted by Life Support Products, Inc. (Irvine, US). The FDA issued a Cleared decision on February 21, 1986, 10 days after receiving the submission on February 11, 1986. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2350.

Submission Details

510(k) Number K860516 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 1986
Decision Date February 21, 1986
Days to Decision 10 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary

Device Classification

Product Code BXY — Flowmeter, Calibration, Gas
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.2350