CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN
FDA 510(k) clearance K131912 · decided 2014-03-06
Clearance details
- K-number
- K131912
- Device name
- CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN
- Applicant
- Teleflex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-06-26
- Decision date
- 2014-03-06
- Days to decision
- 253 days
- Clearance type
- Traditional
- Product code
- BTT
- Device class
- 2
- Regulation number
- 868.5450
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Durham, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit recall (Z-1114-2020) | TELEFLEX MEDICAL INC | 2020-02-07 |
| HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, REF 2414, humid recall (Z-1115-2020) | TELEFLEX MEDICAL INC | 2020-02-07 |
| Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier, Rx Only. recall (Z-1558-2015) | Teleflex Medical | 2015-04-30 |