FDA CDRH’s Office of Device Evaluation “Non-invasive Blood Pressure (NIBP) Monitor Guidance” issued March 10, 1997 as a medical device specific 510(k) Submission guidance. There is a software section in this document that describes the software documentation expected as part of the a 510(k) submission for a non-invasive blood pressure monitors. Note that this document was issued prior to the most recent general software submission guidances including the Off-the-shelf software submission guidance so the requirements of these general guidances should also be considered.