Disposable Hme/Filter

FDA 510(k) K954194 · Engstrom Medical

Substantially Equivalent

510(k) numberK954194

Submission

Device name
Disposable Hme/Filter
Applicant
Engstrom Medical
Sturgis, MI, US
Received
September 6, 1995
Decision date
October 20, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BYD – Condenser, Heat And Moisture (Artificial Nose)
Device class
Class I (low risk)
Regulation
21 CFR 868.5375
Specialty
Anesthesiology

Other 510(k)s with product code BYD

510(k)DeviceApplicantDecision
K955008Heat & Moisture ExchangerBYD · Traditional Intertech Resources, Inc.01/30/1996SE
K953580Heat Moisture ExchangerBYD · Traditional Intertech Resources, Inc.09/15/1995SE
K953507Type 1 & 2 (Humidair I & II)BYD · Traditional Icor AB09/07/1995SE
K953620Warm N Wet Hmef W/Luer AdapterBYD · Traditional Hospitak, Inc.08/25/1995SE
K953619Warm N Wet Hme W/Luer AdapterBYD · Traditional Hospitak, Inc.08/25/1995SE
K953544Humid-Vent 2 Light/Humid-Vent 2 Port LightBYD · Traditional Gibeck, Inc.08/25/1995SE
K953540EeeBYD · Traditional Edentec Corp.08/25/1995SE
K953491Humid-Vent 1 Port/Humid-Vent 1 Port AngleBYD · Traditional Gibeck, Inc.08/25/1995SE
K952845Humid-Vent Trach-VentBYD · Traditional Gibeck, Inc.07/25/1995SE
K952844Humid-Vent 2BYD · Traditional Gibeck, Inc.07/20/1995SE

More from Gibeck, Inc.

510(k)DeviceDecision
K954197Disposable Flex TubeBZA · Traditional 10/26/1995SE

Questions and answers

When was Disposable Hme/Filter cleared by the FDA?

Disposable Hme/Filter (K954194) received a 510(k) decision of Substantially Equivalent on October 20, 1995, 44 days after the submission was received.

What is the product code of K954194?

The FDA product code is BYD – Condenser, Heat And Moisture (Artificial Nose), a Class I (low risk) device regulated under 21 CFR 868.5375.