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FDA 510(k)

PM-8 HEART RATE MONITOR

K-Number: K864748 · 1987-03-20

ApplicantPulse Time Products, Ltd.
Decision Date1987-03-20
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PM-8 HEART RATE MONITOR 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 1987-03-20 under 510(k) number K864748. 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 PM-8 HEART RATE MONITOR?

PM-8 HEART RATE MONITOR is a medical device that received FDA 510(k) clearance on 1987-03-20. The listed applicant is Pulse Time Products, Ltd.. The 510(k) number is K864748.

When did PM-8 HEART RATE MONITOR receive FDA 510(k) clearance?

PM-8 HEART RATE MONITOR received FDA 510(k) clearance on 1987-03-20, under 510(k) number K864748.

Who is the listed applicant for PM-8 HEART RATE MONITOR?

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 PM-8 HEART RATE MONITOR?

The FDA product code for PM-8 HEART RATE MONITOR 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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. MONITORK811425CARDIACMONITORS

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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