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FDA 510(k)

PE-3000 PULSE RATE MONITOR

K-Number: K854198 · 1986-03-13

ApplicantQuantum Life Systems, Inc.
Decision Date1986-03-13
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PE-3000 PULSE RATE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Quantum Life Systems, Inc.. It received FDA 510(k) clearance on 1986-03-13 under 510(k) number K854198. 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 PE-3000 PULSE RATE MONITOR?

PE-3000 PULSE RATE MONITOR is a medical device that received FDA 510(k) clearance on 1986-03-13. The listed applicant is Quantum Life Systems, Inc.. The 510(k) number is K854198.

When did PE-3000 PULSE RATE MONITOR receive FDA 510(k) clearance?

PE-3000 PULSE RATE MONITOR received FDA 510(k) clearance on 1986-03-13, under 510(k) number K854198.

Who is the listed applicant for PE-3000 PULSE RATE MONITOR?

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

What is the FDA product code for PE-3000 PULSE RATE MONITOR?

The FDA product code for PE-3000 PULSE RATE MONITOR is DRT.

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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.

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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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