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FDA 510(k)

Models 3543A, 4343A, 2929A and A843B

K-Number: K170480 · 2017-07-07

ApplicantShanghai PZ Medical Technolgoy Co., Ltd.
Decision Date2017-07-07
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Models 3543A, 4343A, 2929A and A843B is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai PZ Medical Technolgoy Co., Ltd.. It received FDA 510(k) clearance on 2017-07-07 under 510(k) number K170480. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Models 3543A, 4343A, 2929A and A843B?

Models 3543A, 4343A, 2929A and A843B is a medical device that received FDA 510(k) clearance on 2017-07-07. The listed applicant is Shanghai PZ Medical Technolgoy Co., Ltd.. The 510(k) number is K170480.

When did Models 3543A, 4343A, 2929A and A843B receive FDA 510(k) clearance?

Models 3543A, 4343A, 2929A and A843B received FDA 510(k) clearance on 2017-07-07, under 510(k) number K170480.

Who is the listed applicant for Models 3543A, 4343A, 2929A and A843B?

The FDA 510(k) record lists Shanghai PZ Medical Technolgoy Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Models 3543A, 4343A, 2929A and A843B?

The FDA product code for Models 3543A, 4343A, 2929A and A843B is MQB.

Related Devices (Code: MQB)

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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