Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

A8, A9 Anesthesia System

K-Number: K201957 · 2021-03-26

Decision Date2021-03-26
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

A8, A9 Anesthesia System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2021-03-26 under 510(k) number K201957. The device is classified under product code BSZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A8, A9 Anesthesia System?

A8, A9 Anesthesia System is a medical device that received FDA 510(k) clearance on 2021-03-26. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K201957.

When did A8, A9 Anesthesia System receive FDA 510(k) clearance?

A8, A9 Anesthesia System received FDA 510(k) clearance on 2021-03-26, under 510(k) number K201957.

Who is the listed applicant for A8, A9 Anesthesia System?

The FDA 510(k) record lists Shenzhen Mindray Bio-Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A8, A9 Anesthesia System?

The FDA product code for A8, A9 Anesthesia System is BSZ.

Other records listing Shenzhen Mindray Bio-Medical Electronics 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.

View all 88 devices →

Related Devices (Code: BSZ)

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.