Search Results

The SimplyGo™ Breast Pump Kit is an electrically operated suction device used to express and collect milk from the breast(s) of lactating women.

The SimplyGo™ Breast Pump Kit is an electrically operated suction device.

This is an FDA Premarket Notification (510(k)) for the SimplyGo™ Breast Pump Kit. It is a clearance letter, not a study report. Therefore, the detailed information regarding acceptance criteria and a study proving those criteria are met is not contained within this document.

The document states that the FDA has "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This means the device was cleared because it was found to be as safe and effective as a device already on the market, not through a new clinical study demonstrating specific performance against acceptance criteria in the way a PMA (Premarket Approval) would require.

Therefore, I cannot provide the requested information based on the provided text. The 510(k) process relies on demonstrating substantial equivalence to a predicate device, rather than providing new clinical study data with acceptance criteria and performance metrics described in your request.

Ask a specific question about this device