VMT GENTLE-HALER— 510(k) K842988

Name: FDA 510(k) clearance K842988
Creator: U.S. Food and Drug Administration
Published: 1984-08-07

Substantially Equivalent

Vortran Medical Technology 1, Inc.

FDA 510(k) clearance K842988 for VMT GENTLE-HALER, Substantially Equivalent on 1984-08-07. Applicant: Vortran Medical Technology 1, Inc.. Device class: 1.

Clearance details

Applicant: Vortran Medical Technology 1, Inc.
Product code: Code CCQ
Device class: Class 1
Regulation: 21 CFR 868.5640
Advisory panel: Anesthesiology
Date received: 1984-07-30
Decision date: 1984-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CCQ

view all

K972397 — EZ SPRAY1997-09-23
K964956 — E-Z SPACER MASK (SMALL)1997-04-23
K961894 — MDI TUTOR1996-08-14
K961455 — MEDSHIELD/AEROCHAMBER1996-07-25
K960593 — SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-1001996-05-10

More clearances from Vortran Medical Technology 1, Inc.

view all

K202219 — VORTRAN GO2VENT with PEEP Valve2021-02-11
K182292 — VORTRAN APM-Plus2019-09-18
K173914 — VORTRAN Cuff Inflator (VCI)2018-05-25
K162968 — VORTRAN GO2VENT2017-04-10
K153733 — VORTRAN Manometer2016-09-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.