Servo Cart 170

FDA 510(k) K840264 · Siemens Elema AB

Substantially Equivalent

510(k) numberK840264

Submission

Device name
Servo Cart 170
Applicant
Siemens Elema AB
Mchenry, IL, US
Received
January 23, 1984
Decision date
February 4, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BZN – Cart, Emergency, Cardiopulmonary (Excluding Equipment)
Device class
Class I (low risk)
Regulation
21 CFR 868.6175
Specialty
Anesthesiology

Other 510(k)s with product code BZN

510(k)DeviceApplicantDecision
K924373Accuflate Accessorie Cart W/Iv Pole and ClampBZN · Traditional Instrumed, Inc.11/25/1992SE
K872558Cart, Emergency, CardiopulmonaryBZN · Traditional Nico Metal Products Corp.07/24/1987SE
K850761Model Pcx/Emy 525A Microprocesssor Control X-Ray CBZN · Traditional Medicor USA , Ltd.09/19/1985SE
K832697RMP Intubation Equip. Storage TrayBZN · Traditional Rmp Co.12/27/1983SE
K832356Portable Operat. Rm. Monitors HS30/40BZN · Traditional Medtel Pty. , Ltd.10/28/1983SE
K832355Crash CartBZN · Traditional Quinton, Inc.10/28/1983SE
K772320Emergency CartBZN · Traditional Physio-Control Corp.01/03/1978SE

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Questions and answers

When was Servo Cart 170 cleared by the FDA?

Servo Cart 170 (K840264) received a 510(k) decision of Substantially Equivalent on February 4, 1984, 12 days after the submission was received.

What is the product code of K840264?

The FDA product code is BZN – Cart, Emergency, Cardiopulmonary (Excluding Equipment), a Class I (low risk) device regulated under 21 CFR 868.6175.