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FDA 510(k)

POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30

K-Number: K051547 · 2005-07-14

ApplicantTpc Advanced Technology, Inc.
Decision Date2005-07-14
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30 is the device name listed in this FDA 510(k) record. The listed applicant is Tpc Advanced Technology, Inc.. It received FDA 510(k) clearance on 2005-07-14 under 510(k) number K051547. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30?

POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30 is a medical device that received FDA 510(k) clearance on 2005-07-14. The listed applicant is Tpc Advanced Technology, Inc.. The 510(k) number is K051547.

When did POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30 receive FDA 510(k) clearance?

POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30 received FDA 510(k) clearance on 2005-07-14, under 510(k) number K051547.

Who is the listed applicant for POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30?

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

What is the FDA product code for POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30?

The FDA product code for POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30 is ELC.

Related Clinical Trials

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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Other records listing Tpc Advanced Technology, Inc. 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.

K071485TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888K983029POWER PLUS 25K MODEL, S1000, POWER PLUS 30K MODEL,S1001

Related Devices (Code: ELC)

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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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