K042273 - MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY (FDA 510(k) Clearance)

K042273 is an FDA 510(k) clearance for the MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Health Hero Network, Inc. (Mountain View, US). The FDA issued a Cleared decision on August 31, 2004 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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