AUDICOR CA300/CC100 Analyzer with SDB— 510(k) K151433
Substantially EquivalentInovise Medical, Inc.
FDA 510(k) clearance K151433 for AUDICOR CA300/CC100 Analyzer with SDB, Substantially Equivalent on 2016-03-18. Applicant: Inovise Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Inovise Medical, 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
- Beaverton, OR, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.