FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OXEQUIP CONDUCTIVE & NON ANES. BREATH
K Number: K812624
·
Decision Oct 26, 1981
Classifications
1
FEI Numbers
199
Registration Numbers
199
Same Product Code
183
Applicant Total
5
Review Days
41
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Basic Information
- Device Name
- OXEQUIP CONDUCTIVE & NON ANES. BREATH
- K Number
- K812624
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5240
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Oxequip Health Ind.
- Date Received
- September 15, 1981
- Decision Date
- October 26, 1981
- Product Code
- CAI
- 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 |
|---|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
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Other Clearances by Oxequip Health Ind.
| K Number | Device Name | ||
|---|---|---|---|
| K833496 | OXYGEN MONITOR/CONTROLLER | Dec 16, 1983 | Substantially Equivalent |
| K811987 | OXY-QUIK MARK IV OXYGEN INHALATOR | Jul 27, 1981 | Substantially Equivalent |
| K800369 | TRI PAC MOUTH PROP | Feb 28, 1980 | Substantially Equivalent |
| K792356 | OXEQUIP MODEL 34 MED*STAR OXYGEN MONITOR | Dec 4, 1979 | Substantially Equivalent |