FDA 510(k), K030691, FETAL SPIRAL ELECTRODE, MODEL FSE07000

FDA 510(k), K030691, FETAL SPIRAL ELECTRODE, MODEL FSE07000

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510(K) Number: K030691
Device Name: FETAL SPIRAL ELECTRODE, MODEL FSE07000
Manufacturer: CLINICAL INNOVATIONS, INC.
Device Classification Name: Electrode, Circular (Spiral), Scalp And Applicator
Regulation Number: 884.2675
Classification Product Code: HGP
Date Received: 03/05/2003
Decision Date: 09/17/2003
Regulation Medical Specialty: Obstetrics/Gynecology

Total Pages: 93
Fully Redacted Pages: 34
Content Pages: 59

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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