FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SP 120 SOPHISTICATE
K Number: K802251
·
Decision Oct 23, 1980
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
77
Applicant Total
22
Review Days
37
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Basic Information
- Device Name
- SP 120 SOPHISTICATE
- K Number
- K802251
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2100
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Vickers America Medical Corp.
- Date Received
- September 16, 1980
- Decision Date
- October 23, 1980
- Product Code
- JQP
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JQP | Calculator/Data Processing Module, For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Vickers America Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K840823 | TREONIC C30 | Mar 23, 1984 | Substantially Equivalent |
| K831838 | LABORATORY DATA MGMT SYSTEM SDMS | Jan 24, 1984 | Substantially Equivalent |
| K830748 | RESUSCITAIRE | Jun 22, 1983 | Substantially Equivalent |
| K830936 | TREONIC IP5 | Apr 12, 1983 | Substantially Equivalent |
| K813239 | OXYGENAIRE NURING INCUBATOR | Jan 28, 1982 | Substantially Equivalent |
| K813238 | NEOCARE BABY-CONTROLLED INCUBATOR | Jan 22, 1982 | Substantially Equivalent |
| K811865 | VMA PEDIATRIC APNEA MATTRESS | Jul 31, 1981 | Substantially Equivalent |
| K810792 | NEOCARE TEMPERATURE MONITOR | Apr 29, 1981 | Substantially Equivalent |
| K810067 | 140 NEOCARE AIR CONTROLLED INCUBATOR | Mar 11, 1981 | Substantially Equivalent |
| K810571 | NEOCARE OXYGEN MONITOR | Mar 11, 1981 | Substantially Equivalent |