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FDA 510(k)

INFANT CARIDAC MONITOR

K-Number: K812674 · 1981-10-13

ApplicantElectromed Intl., Ltd.
Decision Date1981-10-13
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INFANT CARIDAC MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Electromed Intl., Ltd.. It received FDA 510(k) clearance on 1981-10-13 under 510(k) number K812674. 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 INFANT CARIDAC MONITOR?

INFANT CARIDAC MONITOR is a medical device that received FDA 510(k) clearance on 1981-10-13. The listed applicant is Electromed Intl., Ltd.. The 510(k) number is K812674.

When did INFANT CARIDAC MONITOR receive FDA 510(k) clearance?

INFANT CARIDAC MONITOR received FDA 510(k) clearance on 1981-10-13, under 510(k) number K812674.

Who is the listed applicant for INFANT CARIDAC MONITOR?

The FDA 510(k) record lists Electromed Intl., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFANT CARIDAC MONITOR?

The FDA product code for INFANT CARIDAC MONITOR is DRT.

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Other records listing Electromed Intl., Ltd. as applicant

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.

K003688VIEW READING STATIONK000474VIEW NTK990759VIEW COMK974255CD-R STATION AND VRS-2000K971176VIEW ARCHIVING STATIONK950694COMPACT-X

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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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