EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR
FDA 510(k) clearance K043520 · decided 2005-10-21
Clearance details
- K-number
- K043520
- Device name
- EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR
- Applicant
- Emg Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2004-12-20
- Decision date
- 2005-10-21
- Days to decision
- 305 days
- Clearance type
- Abbreviated
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Baltimore, MD, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Emg Technology Co.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medline EndurO2 Oxygen Concentrator with Oxygen Monitor; Portable oxygen generator; Reorde recall (Z-1473-2008) | Medline Industries Inc | 2008-07-23 |
| Medline EndurO2 Oxygen Concentrator without Oxygen Monitor; Portable oxygen generator; Reo recall (Z-1474-2008) | Medline Industries Inc | 2008-07-23 |