510(k) K231561
K231561 is an FDA 510(k) premarket notification submitted by Guangzhou Homesun Medical Technology Co., Ltd. for the device "Pulmonary Function Tester, Model: A9". The FDA issued a decision of Substantially Equivalent on February 21, 2024. The device falls under product code BTY (Calculator, Predicted Values, Pulmonary Function), a Class II device regulated under 21 CFR 868.1890. Guangzhou Homesun Medical Technology Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 2024
- Date Received
- May 31, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calculator, Predicted Values, Pulmonary Function
- Device Class
- Class II
- Regulation Number
- 868.1890
- Review Panel
- AN
- Submission Type