Skip to content

Cardiocap(Tm) Pulse Oximetry Module Cos-104

by Datex Division Instrumentarium Corp. 510(k)

Active United States

510(k) K873859

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK873859 Date29 Dec 1987ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
DQA
Device Class
Class II
Regulation
21 CFR Part 870.2700
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Datex Division Instrumentarium Corp.

See all devices from Datex Division Instrumentarium Corp. →