SMARTMONITOR 2, MODEL 4000
FDA 510(k) clearance K011597 · decided 2002-01-11
Clearance details
- K-number
- K011597
- Device name
- SMARTMONITOR 2, MODEL 4000
- Applicant
- Respironics Georgia, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-05-24
- Decision date
- 2002-01-11
- Days to decision
- 232 days
- Clearance type
- Abbreviated
- Product code
- FLS
- Device class
- 2
- Regulation number
- 868.2377
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Kennesaw, GA, US
- Third-party review
- No
- Expedited review
- No
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| RESPIRATION MONITOR (K832999) | Litton Medical Electronics | 1984-02-13 |
| MONITORING KIT AMK-1 (K830778) | Alternative Design Systems, Inc. | 1983-10-14 |
| RESPIRATION MONITOR TYPE MR-10 (K822077) | New Dimensions IN Medicine, Inc. | 1982-10-06 |
| CLINICAL DATA APNEA DETECTOR (K821721) | Clinical Data, Inc. | 1982-07-13 |
| SYSTEM I INFANT MONITORING SYS (K820943) | Burr Engineering & Development Co. | 1982-05-03 |
| VENTILATORY EFFORT MONITOR (K810153) | Medicon, Inc. | 1981-02-09 |
| INFANT APNEA MONITOR (K802710) | Douglas Scientific Products | 1980-11-12 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SmartMonitor 2 Infant Apnea Monitor. The monitor is intended for use in the continuous mon recall (Z-1411-2009) | Respironics, Inc. | 2009-05-19 |
| Lead Wire Pin/Socket 24 in 1 pr model number 9520. Filter, mask, and/or accessories for sl recall (Z-1093-2008) | Respironics, Inc. | 2008-04-24 |