The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Aquasens Fluid Monitoring System.
| Device ID | K031213 |
| 510k Number | K031213 |
| Device Name: | AQUASENS FLUID MONITORING SYSTEM |
| Classification | Insufflator, Hysteroscopic |
| Applicant | DAVOL, INC. SUBSIDIARY OF C.R. BARD 100 SOCKANOSSETT CROSSROAD Cranston, RI 02920 |
| Contact | Brian A Kanerviko |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-04-17 |
| Decision Date | 2003-04-30 |
| Summary: | summary |