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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 a medical device manufactured by ZetrOZ Systems, LLC. It received FDA 510(k) clearance on 2023-06-23 under approval 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. It is manufactured by ZetrOZ Systems, LLC. The 510(k) number is K223019.

When was sam 2.0 Long Ultrasound Device approved by the FDA?

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

What company makes sam 2.0 Long Ultrasound Device?

sam 2.0 Long Ultrasound Device is manufactured by ZetrOZ Systems, LLC.

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.

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Other Devices by ZetrOZ Systems, LLC

K191568sam 2.0 Long Duration Ultrasound System K211513sam X1 Long Duration Ultrasound Device K233210sam CS Long Duration Ultrasound Device K260076SAM 3.0 Multi-Hour Continuous Ultrasound Device

Related Devices (Code: PFW)

K191568sam 2.0 Long Duration Ultrasound SystemZetrOZ Systems, LLC K211513sam X1 Long Duration Ultrasound DeviceZetrOZ Systems, LLC K221210PainShield MD PLUSNanovibronix, Inc. K233210sam CS Long Duration Ultrasound DeviceZetrOZ Systems, LLC K260076SAM 3.0 Multi-Hour Continuous Ultrasound DeviceZetrOZ 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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