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FDA 510(k)

Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford

K-Number: K163292 · 2017-09-08

ApplicantSpectra Medical Devices
Decision Date2017-09-08
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford is the device name listed in this FDA 510(k) record. The listed applicant is Spectra Medical Devices. It received FDA 510(k) clearance on 2017-09-08 under 510(k) number K163292. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford?

Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford is a medical device that received FDA 510(k) clearance on 2017-09-08. The listed applicant is Spectra Medical Devices. The 510(k) number is K163292.

When did Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford receive FDA 510(k) clearance?

Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford received FDA 510(k) clearance on 2017-09-08, under 510(k) number K163292.

Who is the listed applicant for Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford?

The FDA 510(k) record lists Spectra Medical Devices as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford?

The FDA product code for Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford is BSP.

Other records listing Spectra Medical Devices 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.

K151069SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle

Related Devices (Code: BSP)

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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