FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 10200 PREMATURE INFANT INCUBATOR
K Number: K862921
·
Decision Apr 1, 1987
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
91
Applicant Total
1
Review Days
243
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
- MODEL 10200 PREMATURE INFANT INCUBATOR
- K Number
- K862921
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5130
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Rotem Industries C/O Medsys, Inc.
- Date Received
- August 1, 1986
- Decision Date
- April 1, 1987
- 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