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FDA 510(k) K022149, CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000, by Cambridge Heart, Inc.

FDA 510(k) K022149, CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000, by Cambridge Heart, Inc.

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510(K) Number: K022149
Device Name: CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
Manufacturer: Cambridge Heart, Inc.
Device Classification Name: Electrocardiograph
Regulation Number: 870.2340
Classification Product Code: DPS
Date Received: 07/02/2002
Decision Date: 07/16/2002
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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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