HOME-AWAY SYSTEM, MODEL 1041
FDA 510(k) clearance K042944 · decided 2005-04-15
Clearance details
- K-number
- K042944
- Device name
- HOME-AWAY SYSTEM, MODEL 1041
- Applicant
- In-X Corporation
- Decision
- Substantially Equivalent
- Date received
- 2004-10-25
- Decision date
- 2005-04-15
- Days to decision
- 172 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Denver, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.