Aquasens Fluid Monitoring System
FDA 510(k) K031213 · Davol, Inc.
510(k) numberK031213
Submission
- Device name
- Aquasens Fluid Monitoring System
- Applicant
- Davol, Inc.
Cranston, RI, US - Received
- April 17, 2003
- Decision date
- April 30, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- HIG – Insufflator, Hysteroscopic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1700
- Specialty
- Obstetrics/Gynecology
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Questions and answers
When was Aquasens Fluid Monitoring System cleared by the FDA?
Aquasens Fluid Monitoring System (K031213) received a 510(k) decision of Substantially Equivalent on April 30, 2003, 13 days after the submission was received.
What is the product code of K031213?
The FDA product code is HIG – Insufflator, Hysteroscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1700.