510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K982034Substantially Equivalent

E-Fax System

Blakbag, Ltd., Division of Coherent Systems, Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982034 is the FDA 510(k) clearance record for E-FAX SYSTEM, a class II device, cleared for Blakbag, Ltd., Division of Coherent Systems on under FDA product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone). FDA records list one 510(k) clearance for Blakbag, Ltd., Division of Coherent Systems. As of , FDA records show no recalls naming K982034.

Clearance record

Decision date
Received
(254 days to decision)
Product code
DXH Transmitters And Receivers, Electrocardiograph, Telephone
Regulation
21 CFR 870.2920
Device class
Class II
Review panel
Cardiovascular
Applicant
Blakbag, Ltd., Division of Coherent Systems 11874 S. Evelyn Cir., Houston TX
510(k) summary
Summary
Third party review
No

Clearances, product code DXH

Trailing 12 months
4 clearances under product code DXH in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DXH, trailing twelve months
MonthClearances
November 20251
December 20252
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260