510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K011516Substantially Equivalent

Infant Flow System, Model M672p

Eme (Electro Medical Equipment), Ltd., Brighton, Sussex, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011516 is the FDA 510(k) clearance record for INFANT FLOW SYSTEM, MODEL M672P, a class II device, cleared for Eme (Electro Medical Equipment) , Ltd. on under FDA product code BZD (Ventilator, Non-Continuous (Respirator)). FDA records list one 510(k) clearance for Eme (Electro Medical Equipment) , Ltd. As of , FDA records show no recalls naming K011516.

Clearance record

Decision date
Received
(22 days to decision)
Product code
BZD Ventilator, Non-Continuous (Respirator)
Regulation
21 CFR 868.5905
Device class
Class II
Review panel
Anesthesiology
Applicant
Eme (Electro Medical Equipment) , Ltd. 60 Gladstone Pl., Brighton, Sussex, GB
510(k) summary
Statement
Third party review
No

Clearances, product code BZD

Trailing 12 months
11 clearances under product code BZD in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code BZD, trailing twelve months
MonthClearances
November 20250
December 20252
January 20262
February 20260
March 20260
April 20262
May 20262
June 20261
July 20261
August 20260
September 20261
October 20260