FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRI PAC MOUTH PROP
K Number: K800369
·
Decision Feb 28, 1980
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
27
Applicant Total
5
Review Days
8
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Basic Information
- Device Name
- TRI PAC MOUTH PROP
- K Number
- K800369
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5070
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Oxequip Health Ind.
- Date Received
- February 20, 1980
- Decision Date
- February 28, 1980
- Product Code
- JXL
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| JXL | Block, Bite | FDA class 2 | Neurology |
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Other Clearances by Oxequip Health Ind.
| K Number | Device Name | ||
|---|---|---|---|
| K833496 | OXYGEN MONITOR/CONTROLLER | Dec 16, 1983 | Substantially Equivalent |
| K812624 | OXEQUIP CONDUCTIVE & NON ANES. BREATH | Oct 26, 1981 | Substantially Equivalent |
| K811987 | OXY-QUIK MARK IV OXYGEN INHALATOR | Jul 27, 1981 | Substantially Equivalent |
| K792356 | OXEQUIP MODEL 34 MED*STAR OXYGEN MONITOR | Dec 4, 1979 | Substantially Equivalent |