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Replacement battery for Nellcor, Inc. 071764 N-10 Pulse Oximeter (insert only), 510(k) Number K844256. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.

Replacement Battery Part Number MS71764

The provided text is a scanned letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain information about acceptance criteria or a study that proves the device meets such criteria.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the device (a replacement battery for a pulse oximeter) was cleared based on its substantial equivalence to a legally marketed predicate device, rather than through a study demonstrating its performance against specific acceptance criteria. The information you are requesting, such as performance metrics, sample sizes, expert qualifications, and ground truth methodologies, would typically be found in a clinical study report or a more detailed technical submission, which is not part of this FDA letter.

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