CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R
FDA 510(k) clearance K063758 · decided 2007-04-23
Clearance details
- K-number
- K063758
- Device name
- CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R
- Applicant
- Teleflex Medical
- Decision
- Substantially Equivalent
- Date received
- 2006-12-19
- Decision date
- 2007-04-23
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- BTT
- Device class
- 2
- Regulation number
- 868.5450
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bannockburn, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Hudson RCI Concha Therm Neptune Humidifier, Rx Only, Product Usage: Usage: Device that is recall (Z-2036-2012) | Teleflex Medical | 2012-07-19 |
| Teleflex Medical, Hudson RCI, Concha Therm Neptune, Heated Humidifier. Product numbers: 42 recall (Z-1040-2010) | Telefelx Medical | 2010-03-09 |