510(k) K232933
K232933 is an FDA 510(k) premarket notification submitted by Healkee Medical Pte, Ltd. for the device "AirKEE P900". The FDA issued a decision of Substantially Equivalent on May 16, 2024. The device falls under product code FRA (Purifier, Air, Ultraviolet, Medical), a Class II device regulated under 21 CFR 880.6500. Healkee Medical Pte, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 2024
- Date Received
- September 20, 2023
- 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