FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NuBorne Infant Warmer
K Number: K173516
·
Decision Aug 17, 2018
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
91
Applicant Total
8
Review Days
276
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
- NuBorne Infant Warmer
- K Number
- K173516
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 880.5130
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- International Biomedical
- Date Received
- November 14, 2017
- Decision Date
- August 17, 2018
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMT), ordered by most recent decision date.
Babyroo TN300
FDA 510(k)
FDA Class 2
·General Hospital
Babyroo TN300
FDA 510(k)
FDA Class 2
·General Hospital
Giraffe Omnibed Carestation CS1
FDA 510(k)
FDA Class 2
·General Hospital
Panda iRes Warmer, Giraffe Warmer
FDA 510(k)
FDA Class 2
·General Hospital
HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable
FDA 510(k)
FDA Class 2
·General Hospital
Hydro-Temp Neonatal Skin Temperature Probe Cover
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by International Biomedical
| K Number | Device Name | ||
|---|---|---|---|
| K221154 | Infant Heel WarmerTM; Heel Snuggler® | Oct 7, 2022 | Substantially Equivalent |
| K221653 | InfaTherm Disposable Infant Warming Mattress | Oct 6, 2022 | Substantially Equivalent |
| K220742 | NxtGen Infant Transport Incubator | Jul 15, 2022 | Substantially Equivalent |
| K193481 | AeroNOx 2.0 Nitric Oxide Titration & Monitoring System | Mar 10, 2020 | Substantially Equivalent |
| K182956 | Puffin Lite Infant Resuscitation System | Jan 18, 2019 | Substantially Equivalent |
| K160238 | Airborne Phototherapy Light | Jun 14, 2016 | Substantially Equivalent |
| K140707 | LIFEBORNE INFANT RESUSCITATOR | May 28, 2014 | Substantially Equivalent |