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FDA 510(k)

ivWatch® Model 400

K-Number: K233881 · 2024-03-15

ApplicantIvwatch, LLC
Decision Date2024-03-15
Product CodePMS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ivWatch® Model 400 is a medical device manufactured by Ivwatch, LLC. It received FDA 510(k) clearance on 2024-03-15 under approval number K233881. The device is classified under product code PMS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ivWatch® Model 400?

ivWatch® Model 400 is a medical device that received FDA 510(k) clearance on 2024-03-15. It is manufactured by Ivwatch, LLC. The 510(k) number is K233881.

When was ivWatch® Model 400 approved by the FDA?

ivWatch® Model 400 received FDA 510(k) clearance on 2024-03-15, under approval number K233881.

What company makes ivWatch® Model 400?

ivWatch® Model 400 is manufactured by Ivwatch, LLC.

What is the FDA product code for ivWatch® Model 400?

The FDA product code for ivWatch® Model 400 is PMS.

Other Devices by Ivwatch, LLC

K162478ivWatch K153605ivWatch Model 400 K192385ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable K222212ivWatch Model 400

Related Devices (Code: PMS)

K162478ivWatchIvwatch, LLC K153605ivWatch Model 400Ivwatch, LLC K192385ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient CableIvwatch, LLC K222212ivWatch Model 400Ivwatch, 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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