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Resubmitted Radioaerosol Cont. System MP-963

by Medipart Jerry Alexander

510(k) K893532

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 NumberK893532 Date21 Aug 1989ClearedStatusActive

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  • Withdrawn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
CBN
Device Class
Class II
Regulation
21 CFR Part 868.5430
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 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 Resubmitted Radioaerosol Cont. System MP-963 is an apparatus for gas-scavenging, classified under FDA device class 2 with product code CBN. It is designed for use in the medical specialty of anesthesiology as indicated by its regulatory classification and advisory committee assignment.

This device received FDA 510(k) clearance K893532 on August 21, 1989, following a traditional review process and was found substantially equivalent (SESE). It is regulated under regulation number 868.5430 and was manufactured by Medipart Jerry Alexander in Cary, Illinois.

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Questions

AI-generated answers, 1 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 Resubmitted Radioaerosol Cont. System MP-963 used for?

    The Resubmitted Radioaerosol Cont. System MP-963 is designed for gas-scavenging in medical settings, specifically indicated for use in the anesthesiology specialty as defined by its FDA product code CBN and advisory committee assignment.

  • How was the Resubmitted Radioaerosol Cont. System MP-963 cleared for market?

    The device received FDA 510(k) clearance under number K893532 on August 21, 1989, following a traditional review process and was determined to be substantially equivalent to a predicate device.

  • Who manufactures the Resubmitted Radioaerosol Cont. System MP-963 and where is it made?

    The Resubmitted Radioaerosol Cont. System MP-963 is manufactured by Medipart Jerry Alexander, located at 607 Spring Beach Rd., Cary, Illinois 60013, United States.