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FDA 510(k)

PULSEOMETER

K-Number: K800500 · 1980-04-08

ApplicantKirklands Sporting Goods Co.
Decision Date1980-04-08
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PULSEOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Kirklands Sporting Goods Co.. It received FDA 510(k) clearance on 1980-04-08 under 510(k) number K800500. 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 PULSEOMETER?

PULSEOMETER is a medical device that received FDA 510(k) clearance on 1980-04-08. The listed applicant is Kirklands Sporting Goods Co.. The 510(k) number is K800500.

When did PULSEOMETER receive FDA 510(k) clearance?

PULSEOMETER received FDA 510(k) clearance on 1980-04-08, under 510(k) number K800500.

Who is the listed applicant for PULSEOMETER?

The FDA 510(k) record lists Kirklands Sporting Goods Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PULSEOMETER?

The FDA product code for PULSEOMETER 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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