Skip to content

PB253 to PB254 Ir - Spectrometer Upgrade Kit

by Datex Division Instrumentarium Corp. 510(k)

Active United States

510(k) K861474

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK861474 Date2 May 1986ClearedStatusActive

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  • Withdrawn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
CBQ
Device Class
Class II
Regulation
21 CFR Part 868.1500
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Other devices from Datex Division Instrumentarium Corp.

See all devices from Datex Division Instrumentarium Corp. →