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FDA 510(k)

DYNASENSE SYSTEM

K-Number: K130752 · 2013-08-15

ApplicantCentauri Medical, Inc.
Decision Date2013-08-15
Product CodeKMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DYNASENSE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Centauri Medical, Inc.. It received FDA 510(k) clearance on 2013-08-15 under 510(k) number K130752. The device is classified under product code KMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNASENSE SYSTEM?

DYNASENSE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-08-15. The listed applicant is Centauri Medical, Inc.. The 510(k) number is K130752.

When did DYNASENSE SYSTEM receive FDA 510(k) clearance?

DYNASENSE SYSTEM received FDA 510(k) clearance on 2013-08-15, under 510(k) number K130752.

Who is the listed applicant for DYNASENSE SYSTEM?

The FDA 510(k) record lists Centauri Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYNASENSE SYSTEM?

The FDA product code for DYNASENSE SYSTEM is KMI.

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Related Devices (Code: KMI)

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.

K131585INTEL-GE CARE INNOVATIONS QUIETCAREIntel-Ge Care Innovations, LLCK101109VIVATRAKWireless Medcare, LLCK090138MOBILECARE MONITOR, MODEL 2100Aframe Digital, Inc.K942770ULTIMAT-SENSOR FOR BED OCCUPANCY MONITORUltimate Development Corp.K943481INFORMER PLUSMicro-Tech Medical, Inc.K933552PM-PAGERHill Engineering

Official Source

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

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