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FDA 510(k)

BRADYCARDIA ALARM

K-Number: K813174 · 1982-01-22

ApplicantDouglas Scientific Products
Decision Date1982-01-22
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BRADYCARDIA ALARM is the device name listed in this FDA 510(k) record. The listed applicant is Douglas Scientific Products. It received FDA 510(k) clearance on 1982-01-22 under 510(k) number K813174. 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 BRADYCARDIA ALARM?

BRADYCARDIA ALARM is a medical device that received FDA 510(k) clearance on 1982-01-22. The listed applicant is Douglas Scientific Products. The 510(k) number is K813174.

When did BRADYCARDIA ALARM receive FDA 510(k) clearance?

BRADYCARDIA ALARM received FDA 510(k) clearance on 1982-01-22, under 510(k) number K813174.

Who is the listed applicant for BRADYCARDIA ALARM?

The FDA 510(k) record lists Douglas Scientific Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRADYCARDIA ALARM?

The FDA product code for BRADYCARDIA ALARM is DRT.

Related Clinical Trials

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.

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Other records listing Douglas Scientific Products 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.

K802710INFANT APNEA MONITOR

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

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

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