FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Infinity Gateway Suite
K Number: K203579
·
Decision Jun 7, 2022
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
116
Applicant Total
48
Review Days
547
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Infinity Gateway Suite
- K Number
- K203579
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Draeger Medical Systems, Inc.
- Date Received
- December 7, 2020
- Decision Date
- June 7, 2022
- Product Code
- MSX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MSX | System, Network And Communication, Physiological Monitors | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MSX), ordered by most recent decision date.
IntelliVue Measurement Rack 6000 (867317)
FDA 510(k)
FDA Class 2
·Cardiovascular
TigerConnect Alarm Management
FDA 510(k)
FDA Class 2
·Cardiovascular
BeneVision Central Monitoring System
FDA 510(k)
FDA Class 2
·Cardiovascular
Central Station
FDA 510(k)
FDA Class 2
·Cardiovascular
ANNE View, Central Hub
FDA 510(k)
FDA Class 2
·Cardiovascular
Hinscope
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Draeger Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243606 | Babyroo TN300 | Jan 17, 2025 | Substantially Equivalent |
| K240312 | Infinity CentralStation Wide | Aug 1, 2024 | Substantially Equivalent |
| K233834 | Infinity Gateway Suite | Jul 12, 2024 | Substantially Equivalent |
| K231477 | Infinity CentralStation Wide, Infinity M300, Infinity M300+ | Oct 17, 2023 | Substantially Equivalent |
| K230278 | Babyroo TN300 | May 30, 2023 | Substantially Equivalent |
| K203088 | Infinity Acute Care System (IACS) Monitoring System | Feb 1, 2022 | Substantially Equivalent |
| K201764 | Infinity Acute Care System (IACS) Monitoring Solution | Dec 9, 2021 | Substantially Equivalent |
| K200859 | Infinity M300 | Aug 28, 2020 | Substantially Equivalent |
| K182977 | Isolette 8000 Plus | Nov 21, 2018 | Substantially Equivalent |
| K172656 | BiliLux | May 1, 2018 | Substantially Equivalent |