AUREFLO MONITORING SYSTEM— 510(k) K112657
Substantially EquivalentTransonic Systems, Inc.
FDA 510(k) clearance K112657 for AUREFLO MONITORING SYSTEM, Substantially Equivalent on 2011-12-21. Applicant: Transonic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Transonic Systems, Inc.
- Product code
- Code DPW
- Device class
- Class 2
- Regulation
- 21 CFR 870.2100
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ithaca, NY, US
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