Servo Humidifier 152 Siemens-Elema AB
FDA 510(k) K844040 · Siemens Elema AB
510(k) numberK844040
Submission
- Device name
- Servo Humidifier 152 Siemens-Elema AB
- Applicant
- Siemens Elema AB
Schaumburg, IL, US - Received
- October 16, 1984
- Decision date
- October 25, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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) | Device | Applicant | Decision |
|---|---|---|---|
| K955008 | Heat & Moisture ExchangerBYD · Traditional | Intertech Resources, Inc. | 01/30/1996SE |
| K954194 | Disposable Hme/FilterBYD · Traditional | Engstrom Medical | 10/20/1995SE |
| K953580 | Heat Moisture ExchangerBYD · Traditional | Intertech Resources, Inc. | 09/15/1995SE |
| K953507 | Type 1 & 2 (Humidair I & II)BYD · Traditional | Icor AB | 09/07/1995SE |
| K953620 | Warm N Wet Hmef W/Luer AdapterBYD · Traditional | Hospitak, Inc. | 08/25/1995SE |
| K953619 | Warm N Wet Hme W/Luer AdapterBYD · Traditional | Hospitak, Inc. | 08/25/1995SE |
| K953544 | Humid-Vent 2 Light/Humid-Vent 2 Port LightBYD · Traditional | Gibeck, Inc. | 08/25/1995SE |
| K953540 | EeeBYD · Traditional | Edentec Corp. | 08/25/1995SE |
| K953491 | Humid-Vent 1 Port/Humid-Vent 1 Port AngleBYD · Traditional | Gibeck, Inc. | 08/25/1995SE |
| K952845 | Humid-Vent Trach-VentBYD · Traditional | Gibeck, Inc. | 07/25/1995SE |
More from Gibeck, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K023354 | Compressor Mini, 115 V, Model 64 81 779 EH81EBTI · Traditional | 09/05/2003SE |
| K010923 | Kion Anaesthesia System, Model 65 03 879 E392EMHX · Abbreviated | 01/23/2002SE |
| K010925 | Servoi Ventilator System, Model 64 87 800 E407ECBK · Abbreviated | 12/18/2001SE |
| K002137 | Cathcor DesktopDQK · Traditional | 10/05/2000SE |
| K001315 | Modification to Kion Anesthesia SystemBSZ · Special | 05/26/2000SE |
| K970839 | Servo Ventilator 300ACBK · Traditional | 10/14/1997ST |
| K960168 | Siemens Servo Screen 390 and Servo Computer Module 990CBK · Traditional | 10/25/1996ST |
| K960010 | Servo Ventilator 300 Computer InterfaceCBK · Traditional | 10/25/1996ST |
| K872278 | Siemens O2-AIR Mixer 965BZR · Traditional | 09/03/1987SE |
| K871354 | Servo Ventilator 900 C/DCBK · Traditional | 07/21/1987SE |
Questions and answers
When was Servo Humidifier 152 Siemens-Elema AB cleared by the FDA?
Servo Humidifier 152 Siemens-Elema AB (K844040) received a 510(k) decision of Substantially Equivalent on October 25, 1984, 9 days after the submission was received.
What is the product code of K844040?
The FDA product code is BYD – Condenser, Heat And Moisture (Artificial Nose), a Class I (low risk) device regulated under 21 CFR 868.5375.