MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

510(K)

SPEQ READINGA premarket notification under 21 CFR Part 807 Subpart E is the route for this code. The submission argues substantial equivalence to a legally marketed predicate, so the engineering question is which predicate the design can actually be compared against, and the evidence question is what testing supports that comparison.

Class II (moderate to high risk): general controls and special controls

SPEQ READINGSpecial controls are the distinguishing feature: performance standards, guidance documents, patient registries or postmarket surveillance named for the device type. Find the special controls before designing the test plan — they usually name the tests.

Device is eligible for The Voluntary Malfunction Summary Reporting Program

SPEQ READINGMalfunctions for this code may be reported in periodic summary form rather than as individual MDRs under 21 CFR Part 803. Eligibility is a property of the product code; using it is a decision the manufacturer makes and must be able to justify.

Not exempt due to Good Manufacturing Practice (GMP)/Quality System

SPEQ READINGThe full Quality Management System Regulation (21 CFR 820, incorporating ISO 13485:2016) applies, and is what an FDA inspection of this device will be conducted against.

Device is not implantable

SPEQ READINGNo implant-specific expectations attach from the classification itself.

Device is not used for life sustaining purposes

SPEQ READINGNo life-sustaining designation attaches to this code.

Device is not a candidate for a third party review program

SPEQ READINGFDA reviews any premarket notification for this code directly.