510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K810588Substantially Equivalent

Synchronizer #208

Brattle Instrument Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810588 is the FDA 510(k) clearance record for SYNCHRONIZER #208, a class I device, cleared for Brattle Instrument Corp. on under FDA product code IXO (Synchronizer, Ecg / Respirator, Radiographic). FDA records list 7 510(k) clearances for Brattle Instrument Corp., from to . As of , FDA records show no recalls naming K810588.

Clearance record

Decision date
Received
(37 days to decision)
Product code
IXO Synchronizer, Ecg / Respirator, Radiographic
Regulation
21 CFR 892.1970
Device class
Class I
Review panel
Radiology
Applicant
Brattle Instrument Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IXO

Trailing 12 months

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

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