The following data is part of a premarket notification filed by Baronova, Inc. with the FDA for Baronova Insufflation System, Baronova Accessory Kit.
| Device ID | K190985 |
| 510k Number | K190985 |
| Device Name: | BAROnova Insufflation System, BAROnova Accessory Kit |
| Classification | Insufflator, Automatic Carbon-dioxide For Endoscope |
| Applicant | BAROnova, Inc. 1551 Industrial Road San Carlos, CA 94070 |
| Contact | Lian Cunningham |
| Correspondent | Lian Cunningham BAROnova, Inc. 1551 Industrial Road San Carlos, CA 94070 |
| Product Code | FCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-15 |
| Decision Date | 2019-05-14 |
| Summary: | summary |