510(k) K871427
K871427 is an FDA 510(k) premarket notification submitted by Viratek, Inc. for the device "(SPAG) MODEL SPAG-2 6000 SERIES". The FDA issued a decision of Substantially Equivalent (with conditions) on October 6, 1987. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Viratek, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESD (Substantially Equivalent (with conditions))
- Decision Date
- October 6, 1987
- Date Received
- April 9, 1987
- 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