FDA 510(k)

Quickie 脉搏（型号 6BC、6SC、6CC、5BC、5CC、6MPC）和 Zippie ZM-310（型号 BC、SC）

K号: K160031 · 2016-07-14

决定日期2016-07-14

产品代码ITI

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决定实质等同

器械摘要

Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC) is the device name listed in this FDA 510(k) record. The listed applicant is Sunrise Medical (Us), LLC. It received FDA 510(k) clearance on 2016-07-14 under 510(k) number K160031. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC)?

Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC) is a medical device that received FDA 510(k) clearance on 2016-07-14. The listed applicant is Sunrise Medical (Us), LLC. The 510(k) number is K160031.

When did Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC) receive FDA 510(k) clearance?

Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC) received FDA 510(k) clearance on 2016-07-14, under 510(k) number K160031.

Who is the listed applicant for Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC)?

The FDA 510(k) record lists Sunrise Medical (Us), LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC)?

The FDA product code for Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC) is ITI.

列明Sunrise Medical (Us), LLC为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K220213Empulse R90 K172384Quickie® Q700-UP M

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。