510(k) K860132
K860132 is an FDA 510(k) premarket notification submitted by Cooper-Hewitt Electric Co. for the device "AIR CARE AIR SANITIZER". The FDA issued a decision of Substantially Equivalent on January 13, 1987. The device falls under product code FRA (Purifier, Air, Ultraviolet, Medical), a Class II device regulated under 21 CFR 880.6500. Cooper-Hewitt Electric Co. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 1987
- Date Received
- January 14, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Purifier, Air, Ultraviolet, Medical
- Device Class
- Class II
- Regulation Number
- 880.6500
- Review Panel
- HO
- Submission Type