INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
FDA 510(k) clearance K031745 · decided 2004-02-13
Clearance details
- K-number
- K031745
- Device name
- INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
- Applicant
- Sensor Medics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-06-05
- Decision date
- 2004-02-13
- Days to decision
- 253 days
- Clearance type
- Traditional
- Product code
- BZD
- Device class
- 2
- Regulation number
- 868.5905
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Yorba Linda, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CUTANIOUS GAS MONITOR (P830008/S003) | Sensor Medics Corp. | 1988-02-29 |
| CUTANIOUS GAS MONITOR (P830008/S002) | Sensor Medics Corp. | 1985-01-11 |
| CUTANIOUS GAS MONITOR (P830008/S001) | Sensor Medics Corp. | 1984-10-29 |