FDA 510(k)

ivWatch Model 400

K-Number: K153605 · 2016-02-11

Decision Date2016-02-11

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 2016-02-11 under approval number K153605. 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 2016-02-11. It is manufactured by Ivwatch, LLC. The 510(k) number is K153605.

When was ivWatch Model 400 approved by the FDA?

ivWatch Model 400 received FDA 510(k) clearance on 2016-02-11, under approval number K153605.

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

Related Devices (Code: PMS)

K162478ivWatchIvwatch, LLC K192385ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient CableIvwatch, LLC K222212ivWatch Model 400Ivwatch, LLC K233881ivWatch® Model 400Ivwatch, LLC

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.