XactTrace Single Use Respiratory Effort Belt System— 510(k) K173793
Substantially EquivalentEmbla Systems
FDA 510(k) clearance K173793 for XactTrace Single Use Respiratory Effort Belt System, Substantially Equivalent on 2019-03-01. Applicant: Embla Systems. Device class: 2.
Clearance details
- Applicant
- Embla Systems
- 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
- Kanata, CA
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