510(k) K220012
K220012 is an FDA 510(k) premarket notification submitted by Bresotec, Inc. for the device "BresoDX1". The FDA issued a decision of Substantially Equivalent on Dec 21, 2022. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 21, 2022
- Date Received
- Jan 4, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilatory Effort Recorder
- Device Class
- Class II
- Regulation Number
- 868.2375
- Review Panel
- AN
- Submission Type
- 510(k)