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FDA 510(k)

CALMTONE

K-Number: K834519 · 1984-01-30

ApplicantThought Technology , Ltd.
Decision Date1984-01-30
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CALMTONE is the device name listed in this FDA 510(k) record. The listed applicant is Thought Technology , Ltd.. It received FDA 510(k) clearance on 1984-01-30 under 510(k) number K834519. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALMTONE?

CALMTONE is a medical device that received FDA 510(k) clearance on 1984-01-30. The listed applicant is Thought Technology , Ltd.. The 510(k) number is K834519.

When did CALMTONE receive FDA 510(k) clearance?

CALMTONE received FDA 510(k) clearance on 1984-01-30, under 510(k) number K834519.

Who is the listed applicant for CALMTONE?

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

What is the FDA product code for CALMTONE?

The FDA product code for CALMTONE is HCC.

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Other records listing Thought Technology , Ltd. as applicant

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Related Devices (Code: HCC)

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

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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