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FDA 510(k)

VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20

K-Number: K190916 · 2019-06-07

ApplicantVitalconnect, Inc.
Decision Date2019-06-07
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 is the device name listed in this FDA 510(k) record. The listed applicant is Vitalconnect, Inc.. It received FDA 510(k) clearance on 2019-06-07 under 510(k) number K190916. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20?

VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 is a medical device that received FDA 510(k) clearance on 2019-06-07. The listed applicant is Vitalconnect, Inc.. The 510(k) number is K190916.

When did VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 receive FDA 510(k) clearance?

VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 received FDA 510(k) clearance on 2019-06-07, under 510(k) number K190916.

Who is the listed applicant for VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20?

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

What is the FDA product code for VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20?

The FDA product code for VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 is DRG.

Other records listing Vitalconnect, Inc. as applicant

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.

K242129VitalRhythmK193343Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)K192757VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20K183078VitalConnect Platform, VitalPatch BiosensorK163453VitalPatch® VitalConnect PlatformK170973VitalWatch Software User Interface

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Related Devices (Code: DRG)

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.

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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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