RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS
FDA 510(k) clearance K034026 · decided 2005-01-12
Clearance details
- K-number
- K034026
- Device name
- RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS
- Applicant
- Fisher & Paykel Healthcare, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2003-12-29
- Decision date
- 2005-01-12
- Days to decision
- 380 days
- Clearance type
- Traditional
- Product code
- BZE
- Device class
- 2
- Regulation number
- 868.5270
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Auckland, NZ
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.