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AlertWatch:OB

by Alertwatch, Inc.

510(k) K173715

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK173715 Date23 Apr 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HGM
Device Class
Class II
Regulation
21 CFR Part 884.2740
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

AlertWatch:OB is a perinatal monitoring system designed for use in obstetrics and gynecology settings. It is a Class II medical device that provides monitoring capabilities for perinatal care.

The device is manufactured by Alertwatch, Inc. and is supplied as a single-use or reusable system, depending on configuration. It is not MRI compatible and requires storage at room temperature. The device has received FDA 510(k) clearance with the product code HGM and is regulated under 884.2740.

Other devices from Alertwatch, Inc.

  • AlertWatch: OR

    Class II

  • AlertWatch:AC

    Class II

  • AlertWatch: OR

    Class II

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is AlertWatch:OB used for?

    AlertWatch:OB is a perinatal monitoring system designed specifically for use in obstetrics and gynecology settings to provide monitoring capabilities for perinatal care.

  • Is AlertWatch:OB single-use or reusable?

    AlertWatch:OB can be supplied as either a single-use or reusable system, depending on the configuration selected by the healthcare facility.

  • What are the storage requirements for AlertWatch:OB?

    AlertWatch:OB requires storage at room temperature and is not MRI compatible, so it should be stored in an appropriate environment away from MRI equipment.

  • What regulatory clearance has AlertWatch:OB received?

    AlertWatch:OB has received FDA 510(k) clearance with the product code HGM and is regulated under 884.2740, making it a Class II medical device.