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FDA 510(k)

CARETONE II

K-Number: K963678 · 1997-02-24

ApplicantAmerican Telecare, Inc.
Decision Date1997-02-24
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARETONE II 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 1997-02-24 under 510(k) number K963678. 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 CARETONE II?

CARETONE II is a medical device that received FDA 510(k) clearance on 1997-02-24. The listed applicant is American Telecare, Inc.. The 510(k) number is K963678.

When did CARETONE II receive FDA 510(k) clearance?

CARETONE II received FDA 510(k) clearance on 1997-02-24, under 510(k) number K963678.

Who is the listed applicant for CARETONE II?

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 CARETONE II?

The FDA product code for CARETONE II is DQD.

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Other records listing American Telecare, Inc. as applicant

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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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