FDA 510(k)

Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration

K号: K200376 · 2020-12-10

决定日期2020-12-10

产品代码OLO

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决定实质等同

器械摘要

Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration is the device name listed in this FDA 510(k) record. The listed applicant is Navbit Pty, Ltd.. It received FDA 510(k) clearance on 2020-12-10 under 510(k) number K200376. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration?

Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration is a medical device that received FDA 510(k) clearance on 2020-12-10. The listed applicant is Navbit Pty, Ltd.. The 510(k) number is K200376.

When did Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration receive FDA 510(k) clearance?

Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration received FDA 510(k) clearance on 2020-12-10, under 510(k) number K200376.

Who is the listed applicant for Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration?

The FDA 510(k) record lists Navbit Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration?

The FDA product code for Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration is OLO.

列明Navbit Pty, Ltd.为申报人的其他记录

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官方来源

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