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FDA 510(k)

TELSTETH TELEMETRIC STETHOSCOPE(TM)

K-Number: K882119 · 1988-08-08

ApplicantQuantsonics, Inc.
Decision Date1988-08-08
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TELSTETH TELEMETRIC STETHOSCOPE(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Quantsonics, Inc.. It received FDA 510(k) clearance on 1988-08-08 under 510(k) number K882119. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TELSTETH TELEMETRIC STETHOSCOPE(TM)?

TELSTETH TELEMETRIC STETHOSCOPE(TM) is a medical device that received FDA 510(k) clearance on 1988-08-08. The listed applicant is Quantsonics, Inc.. The 510(k) number is K882119.

When did TELSTETH TELEMETRIC STETHOSCOPE(TM) receive FDA 510(k) clearance?

TELSTETH TELEMETRIC STETHOSCOPE(TM) received FDA 510(k) clearance on 1988-08-08, under 510(k) number K882119.

Who is the listed applicant for TELSTETH TELEMETRIC STETHOSCOPE(TM)?

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

What is the FDA product code for TELSTETH TELEMETRIC STETHOSCOPE(TM)?

The FDA product code for TELSTETH TELEMETRIC STETHOSCOPE(TM) is DXH. This falls under the Hematology category.

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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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