SCT 3000 HEATED HUMIDIFIER
FDA 510(k) clearance K970478 · decided 1997-07-16
Clearance details
- K-number
- K970478
- Device name
- SCT 3000 HEATED HUMIDIFIER
- Applicant
- Marquest Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-02-07
- Decision date
- 1997-07-16
- Days to decision
- 159 days
- Clearance type
- Traditional
- Product code
- BTT
- Device class
- 2
- Regulation number
- 868.5450
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Englewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.