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FDA 510(k)

AQUASENS FLUID MONITORING SYSTEM

K-Number: K011069 · 2001-08-16

ApplicantDavol Inc., Sub. C. R. Bard, Inc.
Decision Date2001-08-16
Product CodeHIG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AQUASENS FLUID MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Davol Inc., Sub. C. R. Bard, Inc.. It received FDA 510(k) clearance on 2001-08-16 under 510(k) number K011069. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AQUASENS FLUID MONITORING SYSTEM?

AQUASENS FLUID MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2001-08-16. The listed applicant is Davol Inc., Sub. C. R. Bard, Inc.. The 510(k) number is K011069.

When did AQUASENS FLUID MONITORING SYSTEM receive FDA 510(k) clearance?

AQUASENS FLUID MONITORING SYSTEM received FDA 510(k) clearance on 2001-08-16, under 510(k) number K011069.

Who is the listed applicant for AQUASENS FLUID MONITORING SYSTEM?

The FDA 510(k) record lists Davol Inc., Sub. C. R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AQUASENS FLUID MONITORING SYSTEM?

The FDA product code for AQUASENS FLUID MONITORING SYSTEM is HIG.

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Other records listing Davol Inc., Sub. C. R. Bard, Inc. as applicant

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Related Devices (Code: HIG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261706Endomat Select (UP220)KARL STORZ SE & CO. KGK251273Asurys Fluid Management SystemBoston Scientific CorporationK240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)Hologic, Inc.K210628X-FLO Fluid Management SystemThermedx, LLCK201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KGK180735Endomat SelectKarl Storz SE & CO. KG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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