Siemens Dry Air Compressor
FDA 510(k) K871829 · Siemens Elema AB
510(k) numberK871829
Submission
- Device name
- Siemens Dry Air Compressor
- Applicant
- Siemens Elema AB
Schaumburg, IL, US - Received
- May 11, 1987
- Decision date
- June 15, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTI – Compressor, Air, Portable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.6250
- Specialty
- Anesthesiology
Other 510(k)s with product code BTI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K131881 | Ombra Table Top CompressorBTI · Traditional | Trudell Medical Intl. | 10/24/2013SE |
| K113338 | Medical Air CompressorBTI · Traditional | Oricare, Inc. | 08/10/2012SE |
| K091871 | DK50 DSBTI · Special | Ekom S.R.O. | 10/23/2009SE |
| K072634 | Emg Triton -Comp,Model NCA01-XXX SeriesBTI · Traditional | Emg Technology Co., Ltd. | 11/19/2008SE |
| K060781 | Medical Compressor, Models DK50 D and DMBTI · Traditional | Ekom S.R.O. | 10/03/2006SE |
| K051691 | Minimate CompressorBTI · Traditional | Precision Medical, Inc. | 12/09/2005SE |
| K041781 | Ventilair II Medical Air CompressorBTI · Traditional | Hamilton Medical AG | 03/14/2005SE |
| K041406 | Newport C250 Air Compressor Model C250BTI · Traditional | Newport Medical Instruments | 12/15/2004SE |
| K041974 | MED2000 Nebulizer Compressor, Models P3, P4, P5 with NebulizerBTI · Special | Med2000 S.R.L. | 08/24/2004SE |
| K040220 | Medical Air CompressorBTI · Traditional | eVent Medical, Ltd. | 06/09/2004SE |
More from eVent Medical, Ltd.
| 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 Siemens Dry Air Compressor cleared by the FDA?
Siemens Dry Air Compressor (K871829) received a 510(k) decision of Substantially Equivalent on June 15, 1987, 35 days after the submission was received.
What is the product code of K871829?
The FDA product code is BTI – Compressor, Air, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.6250.