Cleared Traditional

K902916 - PRECISION MEDICAL NEB BLOCK
(FDA 510(k) Clearance)

Jul 1990
Decision
20d
Days
Class 1
Risk

K902916 is an FDA 510(k) clearance for the PRECISION MEDICAL NEB BLOCK. This device is classified as a Flowmeter, Calibration, Gas (Class I - General Controls, product code BXY).

Submitted by Precision Medical, Inc. (Northampton, US). The FDA issued a Cleared decision on July 23, 1990, 20 days after receiving the submission on July 3, 1990.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2350.

Submission Details

510(k) Number K902916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1990
Decision Date July 23, 1990
Days to Decision 20 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