FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEO SHIELD
K Number: K852943
·
Decision Nov 8, 1985
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
91
Applicant Total
27
Review Days
120
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
- NEO SHIELD
- K Number
- K852943
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5130
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Gaymar Industries, Inc.
- Date Received
- July 11, 1985
- Decision Date
- November 8, 1985
- 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 Gaymar Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K100585 | MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 | Jan 20, 2011 | Substantially Equivalent |
| K073675 | T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP | May 8, 2008 | Substantially Equivalent |
| K962788 | CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM | Apr 30, 1997 | Substantially Equivalent |
| K963067 | SOF. PRESS EPC 51 SYSTEM | Jan 28, 1997 | Substantially Equivalent |
| K961854 | SPR PLUS II OVERLAY SYSTEM (CL250/CL212 | Aug 9, 1996 | Substantially Equivalent |
| K942881 | TC 3000 | May 23, 1995 | Substantially Equivalent |
| K930345 | TC2000 POWER UNIT AND ACCESSORIES | Aug 6, 1993 | Substantially Equivalent |
| K914921 | SCM-3 AND ACCESSORIES | Mar 12, 1992 | Substantially Equivalent |
| K914805 | TC-1000, TC-1050 SYSTEM | Jan 7, 1992 | Substantially Equivalent |
| K914851 | CLA-1400 SYSTEM | Nov 13, 1991 | Substantially Equivalent |