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CR-9

by Life Science Instrumentation, Inc. 510(k)

Active United States

510(k) K821223

Overview

The Cr-9 is a cardiac monitor, classified as a Class II device. It is used in cardiovascular applications and is substantially equivalent to other devices in its class.

The Cr-9 is supplied as a single unit and is intended for use in a clinical setting. It has been cleared by the FDA under the 510(k) process, with a decision date of 1982-06-17. The device is manufactured by Life Science Instrumentation, Inc. and has a product code of DRT, with a regulation number of 870.2300.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK821223 Date17 Jun 1982ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DRT
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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