BAROnova Insufflation System, BAROnova Accessory Kit— 510(k) K190985

Name: FDA 510(k) clearance K190985
Creator: U.S. Food and Drug Administration
Published: 2019-05-14

Unknown

Baronova, Inc.

FDA 510(k) clearance K190985 for BAROnova Insufflation System, BAROnova Accessory Kit, Unknown on 2019-05-14. Applicant: Baronova, Inc.. Device class: 2.

Clearance details

Applicant: Baronova, Inc.
Product code: Code FCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2019-04-15
Decision date: 2019-05-14
Decision: Unknown
Clearance type: Traditional
Location: San Carlos, CA, US

Download summary PDF View on FDA.gov ↗

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