RESPIRATORY HUMIDIFIER, MODEL MR850
FDA 510(k) clearance K020332 · decided 2003-07-07
Clearance details
- K-number
- K020332
- Device name
- RESPIRATORY HUMIDIFIER, MODEL MR850
- Applicant
- Fisher & Paykel Healthcare, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-01-31
- Decision date
- 2003-07-07
- Days to decision
- 522 days
- Clearance type
- Traditional
- Product code
- BTT
- Device class
- 2
- Regulation number
- 868.5450
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- East Tamaki, Auckland, NZ
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| RT130 and RT131 Neonatal/ Infant Breathing Circuits, heated wire. For use with MR850 Respi recall (Z-0553-05) | Fisher & Paykel Healthcare Inc | 2005-02-18 |