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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 the device name listed in this FDA 510(k) record. The listed applicant is Ivwatch, LLC. It received FDA 510(k) clearance on 2024-03-15 under 510(k) 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. The listed applicant is Ivwatch, LLC. The 510(k) number is K233881.

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

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

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.

K222212ivWatch Model 400K192385ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient CableK162478ivWatchK153605ivWatch Model 400

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.

K222212ivWatch Model 400Ivwatch, LLCK192385ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient CableIvwatch, LLCK162478ivWatchIvwatch, LLCK153605ivWatch 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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