510(k) K233855
K233855 is an FDA 510(k) premarket notification submitted by Enchant Tek Co. , Ltd. for the device "AllPEP". The FDA issued a decision of Substantially Equivalent on February 2, 2024. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690. Enchant Tek Co. , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 2, 2024
- Date Received
- December 5, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spirometer, Therapeutic (Incentive)
- Device Class
- Class II
- Regulation Number
- 868.5690
- Review Panel
- AN
- Submission Type