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Press-O-Test

by Medi-Swiss Corp.

510(k) K822102

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 NumberK822102 Date24 Nov 1982ClearedStatusActive

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  • Withdrawn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
DXN
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
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.

The Press-O-Test is a device classified under the product code DXN. It is substantially equivalent to other devices, as determined by the FDA. The device falls under the advisory committee description of Cardiovascular. The Press-O-Test is a type of device that does not have a detailed description of its function in the provided data.

The Press-O-Test is supplied by Medi-Swiss Corp. and has been authorized with an FDA 510K clearance, specifically with the k number K822102. The device was cleared on November 24, 1982. The provided data does not specify the device's sterility, size, storage, or MRI safety. The Press-O-Test is a single entry in the FDA database with the specified product code and k number.

Other devices from Medi-Swiss Corp.

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 the Press-O-Test used for?

    The Press-O-Test is a cardiovascular device, but its specific function is not detailed in the provided data.

  • Is the Press-O-Test sterile?

    The sterility of the Press-O-Test is not specified in the provided data.

  • What is the regulatory status of the Press-O-Test?

    The Press-O-Test has been authorized with an FDA 510K clearance, specifically with the k number K822102, indicating it is substantially equivalent to other devices.