K233834
- 510(k) number
- K233834
- Device name
- Infinity Gateway Suite
- Applicant
- Draeger Medical Systems, Inc. MA · US
- Product code
- MSX — System, Network And Communication, Physiological Mon
- Decision date
- 2024-07-12
- Date received
- 2023-12-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K233834.pdf
Official FDA record: K233834
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.