510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820943Substantially Equivalent

System I Infant Monitoring Sys

Burr Engineering & Development Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820943 is the FDA 510(k) clearance record for SYSTEM I INFANT MONITORING SYS, a class II device, cleared for Burr Engineering & Development Co. on under FDA product code FLS (Monitor, Apnea, Facility Use). FDA records list one 510(k) clearance for Burr Engineering & Development Co. As of , FDA records show no recalls naming K820943.

Clearance record

Decision date
Received
(27 days to decision)
Product code
FLS Monitor, Apnea, Facility Use
Regulation
21 CFR 868.2377
Device class
Class II
Review panel
Anesthesiology
Applicant
Burr Engineering & Development Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FLS

Trailing 12 months

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

FDA records show no clearances under product code FLS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FLS, 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