510(k) K945161
K945161 is an FDA 510(k) premarket notification submitted by Hogan & Hartson for the device "NORELCO CLEAN AIR SYSTEM CAS950". The FDA issued a decision of Substantially Equivalent on November 28, 1994. The device falls under product code FRF (Cleaner, Air, Medical Recirculating), a Class II device regulated under 21 CFR 880.5045. Hogan & Hartson has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 28, 1994
- Date Received
- October 17, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cleaner, Air, Medical Recirculating
- Device Class
- Class II
- Regulation Number
- 880.5045
- Review Panel
- HO
- Submission Type