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FDA 510(k)

ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable

K-Number: K192385 · 2020-07-02

ApplicantIvwatch, LLC
Decision Date2020-07-02
Product CodePMS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable is the device name listed in this FDA 510(k) record. The listed applicant is Ivwatch, LLC. It received FDA 510(k) clearance on 2020-07-02 under 510(k) number K192385. 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, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable?

ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable is a medical device that received FDA 510(k) clearance on 2020-07-02. The listed applicant is Ivwatch, LLC. The 510(k) number is K192385.

When did ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable receive FDA 510(k) clearance?

ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable received FDA 510(k) clearance on 2020-07-02, under 510(k) number K192385.

Who is the listed applicant for ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable?

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, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable?

The FDA product code for ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable 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 400K162478ivWatchK153605ivWatch 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.

K233881ivWatch® Model 400Ivwatch, LLCK222212ivWatch Model 400Ivwatch, 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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