Aquasens Fluid Monitoring System
FDA 510(k) K011069 · Davol Inc., Sub. C. R. Bard, Inc.
510(k) numberK011069
Submission
- Device name
- Aquasens Fluid Monitoring System
- Applicant
- Davol Inc., Sub. C. R. Bard, Inc.
Canston, RI, US - Received
- April 9, 2001
- Decision date
- August 16, 2001
- 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 (K011069) received a 510(k) decision of Substantially Equivalent on August 16, 2001, 129 days after the submission was received.
What is the product code of K011069?
The FDA product code is HIG – Insufflator, Hysteroscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1700.