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Ipag Micronova Interface #781111

by Robinton Corp.

510(k) K791753

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 NumberK791753 Date2 Oct 1979ClearedStatusActive

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  • Withdrawn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
DXG
Device Class
Class II
Regulation
21 CFR Part 870.1435
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 IPAG MICRONOVA INTERFACE #781111 is a Computer, Diagnostic, Pre-Programmed, Single-Function device as defined in the device data. It is classified as a Class II medical device under FDA regulation 870.1435 and has the product code DXG.

It received FDA 510(k) clearance K791753 on October 2, 1979, following a traditional submission process. The device was found to be substantially equivalent to a predicate device and is associated with the cardiovascular medical specialty. It was manufactured by Robinton Corp. in McHenry, Illinois, United States.

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 IPAG MICRONOVA INTERFACE #781111 used for?

    The IPAG MICRONOVA INTERFACE #781111 is a Computer, Diagnostic, Pre-Programmed, Single-Function device intended for use in the cardiovascular medical specialty, as defined by its FDA classification and product code DXG.

  • How was the IPAG MICRONOVA INTERFACE #781111 cleared for market?

    The device received FDA 510(k) clearance K791753 on October 2, 1979, through a traditional submission process, demonstrating substantial equivalence to a predicate device under regulation 870.1435.

  • Who manufactures the IPAG MICRONOVA INTERFACE #781111 and where is it made?

    The IPAG MICRONOVA INTERFACE #781111 is manufactured by Robinton Corp. in McHenry, Illinois, United States, as specified in the device authorization data.