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FDA 510(k)

BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT

K-Number: K121197 · 2012-08-10

ApplicantPreventice, Inc.
Decision Date2012-08-10
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT is the device name listed in this FDA 510(k) record. The listed applicant is Preventice, Inc.. It received FDA 510(k) clearance on 2012-08-10 under 510(k) number K121197. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT?

BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT is a medical device that received FDA 510(k) clearance on 2012-08-10. The listed applicant is Preventice, Inc.. The 510(k) number is K121197.

When did BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT receive FDA 510(k) clearance?

BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT received FDA 510(k) clearance on 2012-08-10, under 510(k) number K121197.

Who is the listed applicant for BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT?

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

What is the FDA product code for BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT?

The FDA product code for BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT is DSI.

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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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