FDA 510(k)

ivWatch

K-Number: K162478 · 2016-12-22

Decision Date2016-12-22

Product CodePMS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ivWatch is the device name listed in this FDA 510(k) record. The listed applicant is Ivwatch, LLC. It received FDA 510(k) clearance on 2016-12-22 under 510(k) 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. The listed applicant is Ivwatch, LLC. The 510(k) number is K162478.

When did ivWatch receive FDA 510(k) clearance?

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

Who is the listed applicant for ivWatch?

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

What is the FDA product code for ivWatch?

The FDA product code for ivWatch is PMS.

Other records listing Ivwatch, 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.

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

Related Devices (Code: PMS)

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