Model 7355

FDA 510(k) K952491 · Devilbiss Health Care, Inc.

Substantially Equivalent

510(k) numberK952491

Submission

Device name
Model 7355
Applicant
Devilbiss Health Care, Inc.
Somerset, PA, US
Received
May 30, 1995
Decision date
January 31, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BZD – Ventilator, Non-Continuous (Respirator)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5905
Specialty
Anesthesiology

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More from Resmed Corp

510(k)DeviceDecision
K963349Devilbiss 8650DBTI · Traditional 06/13/1997SE
K970289Compressor/Nebulizer #3650CAF · Traditional 04/15/1997SE
K961126Pulse Dose SeriesNFB · Traditional 10/21/1996SE
K950849Model #7354BZD · Traditional 02/08/1996SE
K952249Jet NebulizerCAF · Traditional 01/30/1996SE
K9538155 LPM Oxygen ConcentratorCAW · Traditional 11/09/1995SE
K9520373 LPM Oxygen ConcentratorCAW · Traditional 09/06/1995SE
K946095Devilbiss Model 5500CAF · Traditional 08/24/1995SE
K944611Model# 7500 SurveyorMNR · Traditional 04/21/1995SE
K935979Continuous Positive Airway Pressure CPAP SystemBZD · Traditional 11/10/1994SE

Questions and answers

When was Model 7355 cleared by the FDA?

Model 7355 (K952491) received a 510(k) decision of Substantially Equivalent on January 31, 1996, 246 days after the submission was received.

What is the product code of K952491?

The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.