510(k) K881648
K881648 is an FDA 510(k) premarket notification submitted by Newport Biosystems, Inc. for the device "TRANSFER CONTAINER HUMIDIFIER". The FDA issued a decision of Substantially Equivalent on December 30, 1988. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Newport Biosystems, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 1988
- Date Received
- April 15, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nebulizer (Direct Patient Interface)
- Device Class
- Class II
- Regulation Number
- 868.5630
- Review Panel
- AN
- Submission Type