PRECISION LIQUID OXYGEN SYSTEM
FDA 510(k) clearance K041122 · decided 2004-10-04
Clearance details
- K-number
- K041122
- Device name
- PRECISION LIQUID OXYGEN SYSTEM
- Applicant
- Precision Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-04-29
- Decision date
- 2004-10-04
- Days to decision
- 158 days
- Clearance type
- Traditional
- Product code
- BYJ
- Device class
- 2
- Regulation number
- 868.5655
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Northampton, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Precision Medical- Easy Mate Portable Liquid Oxygen System (container), PM22010 Series, Mo recall (Z-0153-2007) | Precision Medical, Inc. | 2006-11-04 |