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FDA 510(k)

PULSE RATE MONITOR

K-Number: K914595 · 1992-01-31

ApplicantFitness Quest, Inc.
Decision Date1992-01-31
Product CodeDPZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PULSE RATE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Fitness Quest, Inc.. It received FDA 510(k) clearance on 1992-01-31 under 510(k) number K914595. The device is classified under product code DPZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULSE RATE MONITOR?

PULSE RATE MONITOR is a medical device that received FDA 510(k) clearance on 1992-01-31. The listed applicant is Fitness Quest, Inc.. The 510(k) number is K914595.

When did PULSE RATE MONITOR receive FDA 510(k) clearance?

PULSE RATE MONITOR received FDA 510(k) clearance on 1992-01-31, under 510(k) number K914595.

Who is the listed applicant for PULSE RATE MONITOR?

The FDA 510(k) record lists Fitness Quest, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PULSE RATE MONITOR?

The FDA product code for PULSE RATE MONITOR is DPZ.

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 Fitness Quest, Inc. 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.

K921444DIGI SPORTLENS SYSTEM

Related Devices (Code: DPZ)

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.

K042675FLEXI-STAT SP02 EAR SENSORElekon Industries U.S.A., Inc.K040831DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500Datex-Ohmeda, Inc.K012333FLEXI-SITE SP02 EAR SENSOREpic Medical Equipment Services, Inc.K010718FLEXI-SITE SP02 EAR SENSOREpic Medical Equipment Services, Inc.K944760DURA-Y OXYGEN TRANSDUCER, EAR CLIPNellcor, Inc.K942752MARQUETTE EAR PROBE SENSORMarquette Electronics, Inc.

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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