BZNClass I

Cart, Emergency, Cardiopulmonary (Excluding Equipment)

21 CFR 868.6175 / Anesthesiology

BZN is the FDA product code for Cart, Emergency, Cardiopulmonary (Excluding Equipment), a class I device type, regulated under 21 CFR 868.6175. As of 2026-09-10, FDA records hold 8 510(k) clearances under this code, the most recent dated 1992-11-25, and 2 recalls.

Classification record

Product code: BZN
Device name: Cart, Emergency, Cardiopulmonary (Excluding Equipment)
Regulation: 21 CFR 868.6175
Device class: Class I
Review panel: Anesthesiology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: Yes
Third party review eligible: No
Ingested clearances: 8
Ingested recalls: 2

Clearances, product code BZN

By decision year

8 clearances under product code BZN with a decision year between 1978 and 1992, 1983 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code BZN by decision year
Year	Clearances
1978	1
1983	3
1984	1
1985	1
1987	1
1992	1

Applicants with the most clearances

Product code BZN

Applicants holding the most 510(k) clearances under product code BZN
Applicant	Clearances
Instrumed, Inc.	1
Medicor USA, Ltd.	1
Medtel Pty., Ltd.	1
Nico Metal Products Corp.	1
Physio Control, Inc.	1
Quinton, Inc.	1
Rmp Co.	1
Siemens Elema AB	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 132 companies shown, in name order