A device that I found on the FDA website that is similar to ours is the Medick MHM200 Personal Heart Monitor. The device falls under the classification name: Electrocardiograph, Ambulatory, with Analysis Algorithm (Product Code: MLO). I traced this device back through its predicate devices and here's what I found:
2007: Medick MHM200 Personal Heart Monitor, Medick Healthcare Ltd. (K063339)
2001: C. Net 2100, Cardionetics Ltd. (K010396)
2000: R. Test Evolution, Novacor (K993788)
1992: King of Hearts Express (E.X.) Monitor, Instromedix, Inc. (K920984)
The last one did not have a summary posted online, so I was not able to find any additional predicate devices.
Something that I learned from this assignment was that individuals seeking 510(k) clearance don't always use the Proprietary Name of their predicate devices as listed in the 510(k) "summaries." In addition, the Novacor R. Test Evolution's summary cited the wrong 510(k) number for the King of Hearts Express Monitor (K880620 instead of K920984). 510(k) #K880620 is a chemical assay for thryoxine, which is something entirely different from an ECG!
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