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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 a medical device manufactured by Ivwatch, LLC. It received FDA 510(k) clearance on 2020-07-02 under approval 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. It is manufactured by Ivwatch, LLC. The 510(k) number is K192385.

When was ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable approved by the FDA?

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

What company makes ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable?

ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable is manufactured by Ivwatch, LLC.

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.

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Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026) PMID: 42127028 Proposed standards for prosthetic foot reuse and considerations for donation of used prosthetic feet to low-and middle-income countries. PLOS global public health (2026) PMID: 42065230 The need of innovation and of preservation of well-established techniques in the era of MDR for improving outcomes. EFORT open reviews (2026) PMID: 41982627 Cybersecurity breaches in medical devices: analyzing FDA safety communications in response to patient security concerns. Frontiers in digital health (2026)

Other Devices by Ivwatch, LLC

K162478ivWatch K153605ivWatch Model 400 K222212ivWatch Model 400 K233881ivWatch® Model 400

Related Devices (Code: PMS)

K162478ivWatchIvwatch, LLC K153605ivWatch Model 400Ivwatch, LLC K222212ivWatch Model 400Ivwatch, LLC K233881ivWatch® 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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