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FDA 510(k)

sam 2.0 Long Ultrasound Device

K-Number: K223019 · 2023-06-23

ApplicantZetrOZ Systems, LLC
Decision Date2023-06-23
Product CodePFW
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

sam 2.0 Long Ultrasound Device is the device name listed in this FDA 510(k) record. The listed applicant is ZetrOZ Systems, LLC. It received FDA 510(k) clearance on 2023-06-23 under 510(k) number K223019. The device is classified under product code PFW. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the sam 2.0 Long Ultrasound Device?

sam 2.0 Long Ultrasound Device is a medical device that received FDA 510(k) clearance on 2023-06-23. The listed applicant is ZetrOZ Systems, LLC. The 510(k) number is K223019.

When did sam 2.0 Long Ultrasound Device receive FDA 510(k) clearance?

sam 2.0 Long Ultrasound Device received FDA 510(k) clearance on 2023-06-23, under 510(k) number K223019.

Who is the listed applicant for sam 2.0 Long Ultrasound Device?

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

What is the FDA product code for sam 2.0 Long Ultrasound Device?

The FDA product code for sam 2.0 Long Ultrasound Device is PFW.

Other records listing ZetrOZ Systems, LLC 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.

K260076SAM 3.0 Multi-Hour Continuous Ultrasound DeviceK233210sam CS Long Duration Ultrasound DeviceK211513sam X1 Long Duration Ultrasound DeviceK191568sam 2.0 Long Duration Ultrasound System

Related Devices (Code: PFW)

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.

K260076SAM 3.0 Multi-Hour Continuous Ultrasound DeviceZetrOZ Systems, LLCK233210sam CS Long Duration Ultrasound DeviceZetrOZ Systems, LLCK221210PainShield MD PLUSNanovibronix, Inc.K211513sam X1 Long Duration Ultrasound DeviceZetrOZ Systems, LLCK191568sam 2.0 Long Duration Ultrasound SystemZetrOZ Systems, LLC

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.

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