510(k) K823143
K823143 is an FDA 510(k) premarket notification submitted by Seven Harvest Intl. Import & Export for the device "BUBBLE HUMIDIFIERS". The FDA issued a decision of Substantially Equivalent on November 29, 1982. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450. Seven Harvest Intl. Import & Export has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 1982
- Date Received
- October 25, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Humidifier, Respiratory Gas, (Direct Patient Interface)
- Device Class
- Class II
- Regulation Number
- 868.5450
- Review Panel
- AN
- Submission Type