OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830
FDA 510(k) clearance K010747 · decided 2001-05-16
Clearance details
- K-number
- K010747
- Device name
- OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830
- Applicant
- Western Ent.
- Decision
- Substantially Equivalent
- Date received
- 2001-03-13
- Decision date
- 2001-05-16
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- NFB
- Device class
- 2
- Regulation number
- 868.5905
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Westlake, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Western Medica OPC Portable Oxygen Conserving Regulator, Model OPC-830, 1/2 - 5 LPM, packa recall (Z-0054-04) | Western a Scott Fetzer Co | 2003-10-24 |
| Western Medica OPC Portable Oxygen Conserving Regulator, Model LIN-7005, 1/2 - 5 LPM, pack recall (Z-0055-04) | Western a Scott Fetzer Co | 2003-10-24 |
| Western Medica OPC Portable Oxygen Conserving Regulator, Model MDL-7609, 1/2 - 5 LPM, pack recall (Z-0056-04) | Western a Scott Fetzer Co | 2003-10-24 |