510(k) K962534
K962534 is an FDA 510(k) premarket notification submitted by Pegasus Research Corp. for the device "THERA-MIST NEBULIZER MODEL-P3000". The FDA issued a decision of Substantially Equivalent on February 28, 1997. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Pegasus Research Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 1997
- Date Received
- June 28, 1996
- 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