510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801830Substantially Equivalent

Model 9300 Electrocardiovalidator

Del Mar Avionics, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801830 is the FDA 510(k) clearance record for MODEL 9300 ELECTROCARDIOVALIDATOR, a class I device, cleared for Del Mar Avionics on under FDA product code DSF (Recorder, Paper Chart). FDA records list 54 510(k) clearances for Del Mar Avionics, from to . As of , FDA records show no recalls naming K801830.

Clearance record

Decision date
Received
(26 days to decision)
Product code
DSF Recorder, Paper Chart
Regulation
21 CFR 870.2810
Device class
Class I
Review panel
Cardiovascular
Applicant
Del Mar Avionics 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DSF

Trailing 12 months

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

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