Skip to content

Pace 101H

by Sulzer Oscor, Inc.

510(k) K970497

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK970497 Date4 Jun 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
DTE
Device Class
Class II
Regulation
21 CFR Part 870.3600
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 PACE 101H is a single-chamber cardiac pacemaker that functions as an external pulse generator for temporary atrial or ventricular pacing. It supports synchronous operating modes including VVI and AAI, as well as asynchronous modes V00 and A00.

This device is supplied with an enclosure made of insulating material and features an applied part with two patient connections labeled DIFF (black terminal) and INDIFF (red terminal). It has an internal power supply and is authorized under FDA 510(k) K970497 as a Class II device with product code DTE.

Other devices from Sulzer Oscor, Inc.

Questions

AI-generated answers, 28 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 PACE 101H used for?

    The PACE 101H is a single-chamber cardiac pacemaker that functions as an external pulse generator for temporary atrial or ventricular pacing. It supports both synchronous (VVI and AAI) and asynchronous (V00 and A00) operating modes.

  • How is the PACE 101H supplied and what are its connections?

    The device is supplied with an enclosure made of insulating material and features an applied part with two patient connections labeled DIFF (black terminal) and INDIFF (red terminal). It has an internal power supply.

  • What is the regulatory status of the PACE 101H?

    The PACE 101H is authorized under FDA 510(k) K970497 as a Class II device with product code DTE. It is classified as a pulse-generator, pacemaker, external device.

  • Is the PACE 101H reusable or single-use?

    The device data does not specify whether the PACE 101H is designed for single-use or reuse. This information would need to be confirmed in the product's instructions for use or by contacting the manufacturer directly.