510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K930806Substantially Equivalent

Zymed Holter Scanner Model 2010

Agilent Technologies, Inc., Camarillo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930806 is the FDA 510(k) clearance record for ZYMED HOLTER SCANNER MODEL 2010, a class II device, cleared for Agilent Technologies on under FDA product code DQK (Computer, Diagnostic, Programmable). FDA records list 51 510(k) clearances for Agilent Technologies, from to . As of , FDA records show no recalls naming K930806.

Clearance record

Decision date
Received
(433 days to decision)
Product code
DQK Computer, Diagnostic, Programmable
Regulation
21 CFR 870.1425
Device class
Class II
Review panel
Cardiovascular
Applicant
Agilent Technologies 20 N. Aviador St., Camarillo CA
510(k) summary
Statement
Third party review
No

Clearances, product code DQK

Trailing 12 months
25 clearances under product code DQK in the twelve months to October 2026, February 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code DQK, trailing twelve months
MonthClearances
November 20250
December 20254
January 20262
February 20265
March 20260
April 20263
May 20261
June 20263
July 20264
August 20262
September 20261
October 20260