FDA 510(k), K001401, AMT THERAPEUTIC TABLE, MODEL 748AMT

FDA 510(k), K001401, AMT THERAPEUTIC TABLE, MODEL 748AMT

Regular price $302.83 USD
Regular price Sale price $302.83 USD
Sale Sold out

510(K) Number: K001401
Device Name: AMT THERAPEUTIC TABLE, MODEL 748AMT
Manufacturer: AMT MFG., INC.
Device Classification Name: Equipment, Traction, Powered
Regulation Number: 890.5900
Classification Product Code: ITH
Date Received: 05/03/2000
Decision Date: 07/12/2000
Regulation Medical Specialty: Physical Medicine

Total pages: 133
Fully redacted pages: 26
Content pages: 107

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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

View full details