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FDA 510(k)

Strados Remote Electronic Stethoscope Platform (RESP)

K-Number: K201077 · 2020-12-20

ApplicantStrados Labs
Decision Date2020-12-20
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Strados Remote Electronic Stethoscope Platform (RESP) is a medical device manufactured by Strados Labs. It received FDA 510(k) clearance on 2020-12-20 under approval number K201077. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Strados Remote Electronic Stethoscope Platform (RESP)?

Strados Remote Electronic Stethoscope Platform (RESP) is a medical device that received FDA 510(k) clearance on 2020-12-20. It is manufactured by Strados Labs. The 510(k) number is K201077.

When was Strados Remote Electronic Stethoscope Platform (RESP) approved by the FDA?

Strados Remote Electronic Stethoscope Platform (RESP) received FDA 510(k) clearance on 2020-12-20, under approval number K201077.

What company makes Strados Remote Electronic Stethoscope Platform (RESP)?

Strados Remote Electronic Stethoscope Platform (RESP) is manufactured by Strados Labs.

What is the FDA product code for Strados Remote Electronic Stethoscope Platform (RESP)?

The FDA product code for Strados Remote Electronic Stethoscope Platform (RESP) is DSH.

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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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