510(k) K983862
K983862 is an FDA 510(k) premarket notification submitted by Respiratory Support Products, Inc. for the device "CLOUD 1 HUMIDIFICATION SYSTEM". The FDA issued a decision of Substantially Equivalent on May 24, 1999. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450. Respiratory Support Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 24, 1999
- Date Received
- November 2, 1998
- 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