FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 114 TREONIC H150 HAEMOHEATER
K Number: K790936
·
Decision Sep 4, 1979
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
3
Applicant Total
22
Review Days
109
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Basic Information
- Device Name
- MODEL 114 TREONIC H150 HAEMOHEATER
- K Number
- K790936
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.9205
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Vickers America Medical Corp.
- Date Received
- May 18, 1979
- Decision Date
- September 4, 1979
- Product Code
- KZL
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| KZL | Device, Warming. Blood And Plasma | FDA class 2 | Hematology |
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| 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 |