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FDA 510(k)

MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR

K-Number: K961972 · 1997-04-18

ApplicantAequitron Medical, Inc.
Decision Date1997-04-18
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Aequitron Medical, Inc.. It received FDA 510(k) clearance on 1997-04-18 under 510(k) number K961972. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR?

MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR is a medical device that received FDA 510(k) clearance on 1997-04-18. The listed applicant is Aequitron Medical, Inc.. The 510(k) number is K961972.

When did MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR receive FDA 510(k) clearance?

MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR received FDA 510(k) clearance on 1997-04-18, under 510(k) number K961972.

Who is the listed applicant for MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR?

The FDA 510(k) record lists Aequitron Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR?

The FDA product code for MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR is BZQ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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