FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VICKERS MEDICAL MODEL 130 NEAVENT-NEO
K Number: K791713
·
Decision Sep 19, 1979
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
504
Applicant Total
22
Review Days
23
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Basic Information
- Device Name
- VICKERS MEDICAL MODEL 130 NEAVENT-NEO
- K Number
- K791713
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Vickers America Medical Corp.
- Date Received
- August 27, 1979
- Decision Date
- September 19, 1979
- Product Code
- CBK
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | FDA class 2 | Anesthesiology |
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|---|---|---|---|
| K840823 | TREONIC C30 | Mar 23, 1984 | Substantially Equivalent |
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| 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 |