FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Babyroo TN300
K Number: K243606
·
Decision Jan 17, 2025
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
91
Applicant Total
48
Review Days
57
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Basic Information
- Device Name
- Babyroo TN300
- K Number
- K243606
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5130
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Draeger Medical Systems, Inc.
- Date Received
- November 21, 2024
- Decision Date
- January 17, 2025
- Product Code
- FMT
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMT | Warmer, Infant Radiant | FDA class 2 | General Hospital |
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|---|---|---|---|
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| K231477 | Infinity CentralStation Wide, Infinity M300, Infinity M300+ | Oct 17, 2023 | Substantially Equivalent |
| K230278 | Babyroo TN300 | May 30, 2023 | Substantially Equivalent |
| K203579 | Infinity Gateway Suite | Jun 7, 2022 | 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 |