PLIX
FDA 510(k) clearance K050414 · decided 2005-04-11
Clearance details
- K-number
- K050414
- Device name
- PLIX
- Applicant
- Respironics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-02-18
- Decision date
- 2005-04-11
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- BYJ
- Device class
- 2
- Regulation number
- 868.5655
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Murrysville, PA, US
- Third-party review
- Yes
- Expedited review
- No
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|---|---|---|
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| GOLOX-93 (K081779) | Respironics, Inc. | 2008-09-19 |
| MODIFICATION TO: SPIRIT (K080023) | Caire, Inc. | 2008-06-16 |
| RESPIRONICS GOLOX (K072723) | Respironics, Inc. | 2008-03-20 |
| COPD LIQUID OXYGEN PORTABLE, MODEL 300P (K072011) | Copd Partners, Inc. | 2007-10-18 |
| BACKPACK MEDICAL OXYGEN SYSTEM (K071581) | Essex Cryogenics of Missouri, Inc. | 2007-07-11 |
| SPIRIT, MODEL HAS (K050153) | Caire, Inc. | 2005-04-15 |
| PRECISION LIQUID OXYGEN SYSTEM (K041122) | Precision Medical, Inc. | 2004-10-04 |
| LIQUID OXYGEN SYSTEM (K032143) | Micro Technology Services, Inc. | 2004-03-30 |
Recalls involving this device
No recalls on record reference this clearance.