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FDA 510(k)

TANDA MAX OTC SYSTEM

K-Number: K110735 · 2011-08-03

ApplicantPharos Life Corporation
Decision Date2011-08-03
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TANDA MAX OTC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pharos Life Corporation. It received FDA 510(k) clearance on 2011-08-03 under 510(k) number K110735. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TANDA MAX OTC SYSTEM?

TANDA MAX OTC SYSTEM is a medical device that received FDA 510(k) clearance on 2011-08-03. The listed applicant is Pharos Life Corporation. The 510(k) number is K110735.

When did TANDA MAX OTC SYSTEM receive FDA 510(k) clearance?

TANDA MAX OTC SYSTEM received FDA 510(k) clearance on 2011-08-03, under 510(k) number K110735.

Who is the listed applicant for TANDA MAX OTC SYSTEM?

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

What is the FDA product code for TANDA MAX OTC SYSTEM?

The FDA product code for TANDA MAX OTC SYSTEM is OHS.

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Other records listing Pharos Life 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.

K103415TANDA MAXK090008TANDA RESTORE, MODEL PTSCSK080591TANDA SKINCARE SYSTEM, MODEL: PTSCSK070185TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001

Related Devices (Code: OHS)

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

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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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