FDA 510(k), K952542, ACKRAD ESOPHAGEAL BALLOON CATHETER SET

FDA 510(k), K952542, ACKRAD ESOPHAGEAL BALLOON CATHETER SET

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510(K) Number: K952542
Device Name: ACKRAD ESOPHAGEAL BALLOON CATHETER SET
Manufacturer: ACKRAD LABORATORIES
Device Classification Name: Calculator, Pulmonary Function Data
Regulation Number: 868.1880
Classification Product Code: BZC
Date Received: 05/23/1995
Decision Date: 04/23/1996
Regulation Medical Specialty: Anesthesiology

114 pages (39 of 153 original pages are fully redacted)

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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