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FDA 510(k)

HS186B Scooter

K-Number: K222711 · 2023-01-09

Decision Date2023-01-09
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HS186B Scooter is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Master Machinery Manufacturing Co.,Ltd. It received FDA 510(k) clearance on 2023-01-09 under 510(k) number K222711. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HS186B Scooter?

HS186B Scooter is a medical device that received FDA 510(k) clearance on 2023-01-09. The listed applicant is Suzhou Master Machinery Manufacturing Co.,Ltd. The 510(k) number is K222711.

When did HS186B Scooter receive FDA 510(k) clearance?

HS186B Scooter received FDA 510(k) clearance on 2023-01-09, under 510(k) number K222711.

Who is the listed applicant for HS186B Scooter?

The FDA 510(k) record lists Suzhou Master Machinery Manufacturing Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HS186B Scooter?

The FDA product code for HS186B Scooter is INI.

Other records listing Suzhou Master Machinery Manufacturing Co.,Ltd 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.

Related Devices (Code: INI)

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.

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.