FDA 510(k), K121197, BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT

FDA 510(k), K121197, BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT

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510(K) Number: K121197
Device Name: BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT
Manufacturer: DREW PALIN
Device Classification Name: Detector And Alarm, Arrhythmia
Regulation Number: DSI
Classification Product Code: KXA
Date Received: 04/19/2012
Decision Date: 08/10/2012
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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