510(k) K032809
K032809 is an FDA 510(k) premarket notification submitted by Respironics Healthscan, Inc. for the device "HOSPITAL SPACER". The FDA issued a decision of Substantially Equivalent on November 13, 2003. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Respironics Healthscan, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 13, 2003
- Date Received
- September 9, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Nebulizer (Direct Patient Interface)
- Device Class
- Class II
- Regulation Number
- 868.5630
- Review Panel
- AN
- Submission Type