# K961972: Model Ami Infant Central Aphea/Heart Rate Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Aequitron Medical, Inc.
- Decided: Apr 18, 1997 after 333 days
- Product code: BZQ (Monitor, Breathing Frequency)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Aequitron Model 9550: named in the summary without a submission number

## Most influential descendants
- K991087: Hannah Wireless Vital Signs Monitor (2000), 0 descendants of its own

## Indications for use
Use of the Ami Infant Central Apnea/Heart Rate Monitor is indicated for the continuous monitoring of an infant's heart rate and respiration rate in a home, hospital or portable environment. Continuous monitoring is indicated for infants whose physical condition may result or has resulted in an instability in heart rate or respiration which may become detrimental to the infant. Conditions which may require monitoring include (not all inclusive): Prematurity Respiratory dysfunction Neurologic dysfunction Matemnal drug abuse Cardiovascular dysfunction

Source page: https://510kreport.com/device/K961972
Methodology: https://510kreport.com/methodology