Connection Cable for Synchronization of Two Servo
FDA 510(k) K850374 · Siemens Elema AB
510(k) numberK850374
Submission
- Device name
- Connection Cable for Synchronization of Two Servo
- Applicant
- Siemens Elema AB
Schaumburg, IL, US - Received
- January 31, 1985
- Decision date
- April 25, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CBK – Ventilator, Continuous, Facility Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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More from Flight Medical Innovations , 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 Connection Cable for Synchronization of Two Servo cleared by the FDA?
Connection Cable for Synchronization of Two Servo (K850374) received a 510(k) decision of Substantially Equivalent on April 25, 1985, 84 days after the submission was received.
What is the product code of K850374?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.