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FDA 510(k)

TELESENTRY, MODEL TS01

K-Number: K092947 · 2010-02-26

ApplicantScottcare Corporation
Decision Date2010-02-26
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TELESENTRY, MODEL TS01 is the device name listed in this FDA 510(k) record. The listed applicant is Scottcare Corporation. It received FDA 510(k) clearance on 2010-02-26 under 510(k) number K092947. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TELESENTRY, MODEL TS01?

TELESENTRY, MODEL TS01 is a medical device that received FDA 510(k) clearance on 2010-02-26. The listed applicant is Scottcare Corporation. The 510(k) number is K092947.

When did TELESENTRY, MODEL TS01 receive FDA 510(k) clearance?

TELESENTRY, MODEL TS01 received FDA 510(k) clearance on 2010-02-26, under 510(k) number K092947.

Who is the listed applicant for TELESENTRY, MODEL TS01?

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

What is the FDA product code for TELESENTRY, MODEL TS01?

The FDA product code for TELESENTRY, MODEL TS01 is DSI.

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Other records listing Scottcare Corporation as applicant

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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Related Devices (Code: DSI)

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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