FDA 510(k), K802146, AQUASONIC 100 ULTRASOUND TRANS. GEL,

FDA 510(k), K802146, AQUASONIC 100 ULTRASOUND TRANS. GEL,

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510(K) Number: K802146
Device Name: AQUASONIC 100 ULTRASOUND TRANS. GEL,
Manufacturer: PARKER LABORATORIES, INC.
Device Classification Name: system, imaging, pulsed echo, ultrasonic
Regulation Number: 892.1560
Classification Product Code: IYO
Date Received: 09/05/1980
Decision Date: 10/10/1980
Regulation Medical Specialty: Radiology

Total pages: 29
Fully redacted pages: 17
Content pages: 12

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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