510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K840264Substantially Equivalent

Servo Cart 170

Siemens Elema AB, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840264 is the FDA 510(k) clearance record for SERVO CART 170, a class I device, cleared for Siemens Elema AB on under FDA product code BZN (Cart, Emergency, Cardiopulmonary (Excluding Equipment)). FDA records list 63 510(k) clearances for Siemens Elema AB, from to . As of , FDA records show no recalls naming K840264.

Clearance record

Decision date
Received
(12 days to decision)
Product code
BZN Cart, Emergency, Cardiopulmonary (Excluding Equipment)
Regulation
21 CFR 868.6175
Device class
Class I
Review panel
Anesthesiology
Applicant
Siemens Elema AB 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BZN

Trailing 12 months

FDA records hold no clearances under product code BZN in the trailing twelve months.

FDA records show no clearances under product code BZN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BZN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260