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FDA 510(k)

CARDIACMONITORS

K-Number: K811425 · 1981-09-16

ApplicantPulse Time Products, Ltd.
Decision Date1981-09-16
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIACMONITORS is the device name listed in this FDA 510(k) record. The listed applicant is Pulse Time Products, Ltd.. It received FDA 510(k) clearance on 1981-09-16 under 510(k) number K811425. 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 CARDIACMONITORS?

CARDIACMONITORS is a medical device that received FDA 510(k) clearance on 1981-09-16. The listed applicant is Pulse Time Products, Ltd.. The 510(k) number is K811425.

When did CARDIACMONITORS receive FDA 510(k) clearance?

CARDIACMONITORS received FDA 510(k) clearance on 1981-09-16, under 510(k) number K811425.

Who is the listed applicant for CARDIACMONITORS?

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

What is the FDA product code for CARDIACMONITORS?

The FDA product code for CARDIACMONITORS 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 Pulse Time Products, 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.

K901392BP50 BLOOD PRESSURE AND PULSE MONITORK892795PULSE TIME PRODUCTS LIMITED, PM-3K892794PULSE TIME PRODUCTS LIMITED, PM-2K864411PULSE/B.P. MONITORK864748PM-8 HEART RATE 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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