FDA 510(k) K242152, SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141), by Epic Medical Pte. , Ltd.

FDA 510(k) K242152, SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141), by Epic Medical Pte. , Ltd.

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Device Classification Name: Pump, Infusion, Elastomeric
510(k) Number: K242152
Device Name: SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)
Applicant: Epic Medical Pte. , Ltd.
Regulation Number: 880.5725
Classification Product Code: MEB
Date Received: 07/23/2024
Decision Date: 10/07/2024
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
510k Review Panel: General Hospital

Total number of pages: 396
Fully redacted pages: 186
Content pages: 210

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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