FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OHIO GC INCUBATOR
K Number: K802640
·
Decision Nov 12, 1980
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
84
Applicant Total
47
Review Days
20
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Basic Information
- Device Name
- OHIO GC INCUBATOR
- K Number
- K802640
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5400
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Ohio Medical Products
- Date Received
- October 23, 1980
- Decision Date
- November 12, 1980
- Product Code
- FMZ
- 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 |
|---|---|---|---|
| FMZ | Incubator, Neonatal | FDA class 2 | General Hospital |
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Other Clearances by Ohio Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K841733 | OHIO WASTE GAS SCAVENGING RESERVOIR | Jul 11, 1984 | Substantially Equivalent |
| K842003 | OHIO WASTE GAS SCAVENGING INTERFACE | May 23, 1984 | Substantially Equivalent |
| K840356 | OHIO UNITROL II ANESTHESIA GAS MACHINE | Apr 20, 1984 | Substantially Equivalent |
| K841274 | BAG-TO-VENTILATOR SELECTOR VALVE | Apr 13, 1984 | Substantially Equivalent |
| K840967 | OHIO HEAT REFLECTING PATCH | Mar 23, 1984 | Substantially Equivalent |
| K840858 | OHIO 3300 INFANT WARMER SYSTEM | Mar 23, 1984 | Substantially Equivalent |
| K840857 | OHIO 3000 INFANT WARMER SYSTEM | Mar 23, 1984 | Substantially Equivalent |
| K840453 | MEDISHIELD PVM RESPIROMETER | Mar 2, 1984 | Substantially Equivalent |
| K840452 | PREMIUM DABM DISPOS. ANES. BREATH MASK | Feb 17, 1984 | Substantially Equivalent |
| K833335 | MODULUS II ANESTHESIA GAS MACHINE | Nov 14, 1983 | Substantially Equivalent |