Servo Humidifier 153

FDA 510(k) K852601 · Siemens Elema AB

Substantially Equivalent

510(k) numberK852601

Submission

Device name
Servo Humidifier 153
Applicant
Siemens Elema AB
Schaumburg, IL, US
Received
June 19, 1985
Decision date
July 8, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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
K954194Disposable Hme/FilterBYD · Traditional Engstrom Medical10/20/1995SE
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

More from Gibeck, Inc.

510(k)DeviceDecision
K023354Compressor Mini, 115 V, Model 64 81 779 EH81EBTI · Traditional 09/05/2003SE
K010923Kion Anaesthesia System, Model 65 03 879 E392EMHX · Abbreviated 01/23/2002SE
K010925Servoi Ventilator System, Model 64 87 800 E407ECBK · Abbreviated 12/18/2001SE
K002137Cathcor DesktopDQK · Traditional 10/05/2000SE
K001315Modification to Kion Anesthesia SystemBSZ · Special 05/26/2000SE
K970839Servo Ventilator 300ACBK · Traditional 10/14/1997ST
K960168Siemens Servo Screen 390 and Servo Computer Module 990CBK · Traditional 10/25/1996ST
K960010Servo Ventilator 300 Computer InterfaceCBK · Traditional 10/25/1996ST
K872278Siemens O2-AIR Mixer 965BZR · Traditional 09/03/1987SE
K871354Servo Ventilator 900 C/DCBK · Traditional 07/21/1987SE

Questions and answers

When was Servo Humidifier 153 cleared by the FDA?

Servo Humidifier 153 (K852601) received a 510(k) decision of Substantially Equivalent on July 8, 1985, 19 days after the submission was received.

What is the product code of K852601?

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