510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K891405Substantially Equivalent

Bms-2000 Mobile EEG System

Buckman Co., Inc., Martinez CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891405 is the FDA 510(k) clearance record for BMS-2000 MOBILE EEG SYSTEM, a class II device, cleared for Buckman Co., Inc. on under FDA product code GYE (Encephalogram Telemetry System). FDA records list 111 510(k) clearances for Buckman Co., Inc., from to . As of , FDA records show one recall naming K891405.

Clearance record

Decision date
Received
(141 days to decision)
Product code
GYE Encephalogram Telemetry System
Regulation
21 CFR 882.1855
Device class
Class II
Review panel
Neurology
Applicant
Buckman Co., Inc. 921 Calle Verde, Martinez CA
Third party review
No

Clearances, product code GYE

Trailing 12 months

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

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