Cleared Traditional

K851460 - NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA
(FDA 510(k) Clearance)

K851460 · Telectronics, Inc. · Anesthesiology
May 1985
Decision
29d
Days
Class 1
Risk

K851460 is an FDA 510(k) clearance for the NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA. This device is classified as a Flowmeter, Calibration, Gas (Class I — General Controls, product code BXY).

Submitted by Telectronics, Inc. (Suffield, US). The FDA issued a Cleared decision on May 10, 1985, 29 days after receiving the submission on April 11, 1985.

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

Submission Details

510(k) Number K851460 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1985
Decision Date May 10, 1985
Days to Decision 29 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