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Pulsar Pulse Monitor Watch

by Time Computer, Inc. (Tci)

510(k) K760710

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 NumberK760710 Date2 Dec 1976ClearedStatusActive

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  • Withdrawn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
DRT
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

The Pulsar Pulse Monitor Watch is a cardiac monitoring device designed to measure and display pulse rate. It functions as a personal tachometer that provides real-time heart rate readings to the user.

This device is supplied as a wearable watch and is intended for personal use. It has received FDA 510(k) clearance with the product code DRT and is classified as a Class II medical device for cardiac monitoring. The device is not specified as single-use or reusable, and no MRI safety information is provided in the data.

Questions

AI-generated answers, 23 Sep 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 the Pulsar Pulse Monitor Watch used for?

    The Pulsar Pulse Monitor Watch is designed to measure and display pulse rate, functioning as a personal tachometer that provides real-time heart rate readings to the user for monitoring purposes.

  • How is the Pulsar Pulse Monitor Watch supplied?

    The device is supplied as a wearable watch intended for personal use. It is not specified as single-use or reusable in the provided information.

  • What is the regulatory classification of the Pulsar Pulse Monitor Watch?

    The device has received FDA 510(k) clearance with product code DRT and is classified as a Class II medical device for cardiac monitoring. It was cleared on December 2, 1976, with the K number K760710.

  • Is the Pulsar Pulse Monitor Watch MRI safe?

    No MRI safety information is provided in the device data, so its safety in MRI environments cannot be determined from the available information.