Infinity Picco Pod, Model MS16734
FDA 510(k) K073113 · Draeger Medical Systems, Inc.
510(k) numberK073113
Submission
- Device name
- Infinity Picco Pod, Model MS16734
- Applicant
- Draeger Medical Systems, Inc.
Andover, MA, US - Received
- November 5, 2007
- Decision date
- January 3, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1435
- Specialty
- Cardiovascular
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| K231477 | Infinity CentralStation Wide, Infinity M300, Infinity M300+MHX · Traditional | 10/17/2023SE |
| K230278 | Babyroo TN300FMT · Traditional | 05/30/2023SE |
| K203579 | Infinity Gateway SuiteMSX · Traditional | 06/07/2022SE |
| K203088 | Infinity Acute Care System (IACS) Monitoring SystemMHX · Traditional | 02/01/2022SE |
| K201764 | Infinity Acute Care System (IACS) Monitoring SolutionMHX · Traditional | 12/09/2021SE |
| K200859 | Infinity M300MHX · Traditional | 08/28/2020SE |
Questions and answers
When was Infinity Picco Pod, Model MS16734 cleared by the FDA?
Infinity Picco Pod, Model MS16734 (K073113) received a 510(k) decision of Substantially Equivalent on January 3, 2008, 59 days after the submission was received.
What is the product code of K073113?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.