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FDA 510(k)

HEART RATE/RESPIRATION SIMULATOR 8310

K-Number: K841363 · 1984-10-02

ApplicantAequitron Medical, Inc.
Decision Date1984-10-02
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEART RATE/RESPIRATION SIMULATOR 8310 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 1984-10-02 under 510(k) number K841363. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEART RATE/RESPIRATION SIMULATOR 8310?

HEART RATE/RESPIRATION SIMULATOR 8310 is a medical device that received FDA 510(k) clearance on 1984-10-02. The listed applicant is Aequitron Medical, Inc.. The 510(k) number is K841363.

When did HEART RATE/RESPIRATION SIMULATOR 8310 receive FDA 510(k) clearance?

HEART RATE/RESPIRATION SIMULATOR 8310 received FDA 510(k) clearance on 1984-10-02, under 510(k) number K841363.

Who is the listed applicant for HEART RATE/RESPIRATION SIMULATOR 8310?

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 HEART RATE/RESPIRATION SIMULATOR 8310?

The FDA product code for HEART RATE/RESPIRATION SIMULATOR 8310 is DRT.

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Other records listing Aequitron Medical, Inc. as applicant

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K961972MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITORK952880MODEL LP-1000 VOLUME VENTILATORK944654OXYGEN CONCENTRATION INDICATORK914424MODEL 6213 REMOTE ALARMK915381PORTABLE OXYGEN GENERATORK911399NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST)

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Related Devices (Code: DRT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.

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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