H2 HEATED HUMIDIFIER
FDA 510(k) clearance K030090 · decided 2003-01-24
Clearance details
- K-number
- K030090
- Device name
- H2 HEATED HUMIDIFIER
- Applicant
- Respironics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-01-10
- Decision date
- 2003-01-24
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- BTT
- Device class
- 2
- Regulation number
- 868.5450
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Murrysville, PA, US
- Third-party review
- Yes
- 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.