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FDA 510(k)

ivWatch

K-Number: K162478 · 2016-12-22

ApplicantIvwatch, LLC
Decision Date2016-12-22
Product CodePMS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ivWatch is a medical device manufactured by Ivwatch, LLC. It received FDA 510(k) clearance on 2016-12-22 under approval number K162478. 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?

ivWatch is a medical device that received FDA 510(k) clearance on 2016-12-22. It is manufactured by Ivwatch, LLC. The 510(k) number is K162478.

When was ivWatch approved by the FDA?

ivWatch received FDA 510(k) clearance on 2016-12-22, under approval number K162478.

What company makes ivWatch?

ivWatch is manufactured by Ivwatch, LLC.

What is the FDA product code for ivWatch?

The FDA product code for ivWatch is PMS.

Other Devices by Ivwatch, LLC

K153605ivWatch Model 400 K192385ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable K222212ivWatch Model 400 K233881ivWatch® Model 400

Related Devices (Code: PMS)

K153605ivWatch Model 400Ivwatch, LLC K192385ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient CableIvwatch, LLC K222212ivWatch Model 400Ivwatch, LLC K233881ivWatch® 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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