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Polycord II

by Technetics, Inc.

510(k) K880303

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 NumberK880303 Date5 Dec 1988ClearedStatusActive

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  • Withdrawn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
DSH
Device Class
Class II
Regulation
21 CFR Part 870.2800
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Polycord II is a medical magnetic tape recorder device. It is designed for use within the cardiovascular medical specialty.

This device is authorized under FDA 510(k) clearance K880303. It is manufactured by Technetics, Inc., located in El Cajon, California.

Questions

AI-generated answers, 26 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 primary function of the Polycord II?

    The Polycord II is a medical magnetic tape recorder specifically designed for use within the cardiovascular medical specialty to support clinical recording needs.

  • Who is the manufacturer of this device?

    The Polycord II is manufactured by Technetics, Inc., which is located in El Cajon, California.

  • Is this device authorized for use?

    Yes, the Polycord II is authorized under FDA 510(k) clearance K880303, which indicates the device has been found to be substantially equivalent to other legally marketed devices.