510(k) K161295
K161295 is an FDA 510(k) premarket notification submitted by Pulmone Advanced Medical Devices, Ltd. for the device "MiniBox +". The FDA issued a decision of Substantially Equivalent on October 21, 2016. The device falls under product code BZC (Calculator, Pulmonary Function Data), a Class II device regulated under 21 CFR 868.1880. Pulmone Advanced Medical Devices, Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 2016
- Date Received
- May 9, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calculator, Pulmonary Function Data
- Device Class
- Class II
- Regulation Number
- 868.1880
- Review Panel
- AN
- Submission Type