BresoDX1— 510(k) K220012
Substantially EquivalentBresotec, Inc.
FDA 510(k) clearance K220012 for BresoDX1, Substantially Equivalent on 2022-12-21. Applicant: Bresotec, Inc.. Device class: 2.
Clearance details
- Applicant
- Bresotec, Inc.
- Product code
- Code MNR
- Device class
- Class 2
- Regulation
- 21 CFR 868.2375
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Toronto, CA
Recent devices under product code MNR
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