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FDA 510(k)

TELPHONIC STETHOSCOPE

K-Number: K945638 · 1995-05-17

ApplicantAmerican Telecare, Inc.
Decision Date1995-05-17
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TELPHONIC STETHOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is American Telecare, Inc.. It received FDA 510(k) clearance on 1995-05-17 under 510(k) number K945638. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TELPHONIC STETHOSCOPE?

TELPHONIC STETHOSCOPE is a medical device that received FDA 510(k) clearance on 1995-05-17. The listed applicant is American Telecare, Inc.. The 510(k) number is K945638.

When did TELPHONIC STETHOSCOPE receive FDA 510(k) clearance?

TELPHONIC STETHOSCOPE received FDA 510(k) clearance on 1995-05-17, under 510(k) number K945638.

Who is the listed applicant for TELPHONIC STETHOSCOPE?

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

What is the FDA product code for TELPHONIC STETHOSCOPE?

The FDA product code for TELPHONIC STETHOSCOPE is DQD.

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Other records listing American Telecare, Inc. as applicant

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Related Devices (Code: DQD)

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.

K261494Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730)Shanghai Hulu Devices Co., Ltd.K261694CORE 300 Digital StethoscopeEko Health, Inc.K252915AiSteth®Ai Health Highway India Pvt., Ltd.K252089Tyto Stethoscope (G3)Tyto Care , Ltd.K252076Kneevoice Cartilage Evaluation System (750-3600-001)Kneevoice, Inc.K252284eMurmur Heart AICsd Labs

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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