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FDA 510(k)

ivWatch Model 400

K-Number: K153605 · 2016-02-11

ApplicantIvwatch, LLC
Decision Date2016-02-11
Product CodePMS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ivWatch Model 400 is the device name listed in this FDA 510(k) record. The listed applicant is Ivwatch, LLC. It received FDA 510(k) clearance on 2016-02-11 under 510(k) 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. The listed applicant is Ivwatch, LLC. The 510(k) number is K153605.

When did ivWatch Model 400 receive FDA 510(k) clearance?

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

Who is the listed applicant for ivWatch Model 400?

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 Model 400?

The FDA product code for ivWatch Model 400 is PMS.

Related Clinical Trials

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.

NCT07228416Milky Way Sensor Motion ValidationCOMPLETED

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 400K222212ivWatch Model 400K192385ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient CableK162478ivWatch

Related Devices (Code: PMS)

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 400Ivwatch, LLCK222212ivWatch Model 400Ivwatch, LLCK192385ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient CableIvwatch, LLCK162478ivWatchIvwatch, 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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