510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K893561Substantially Equivalent

Edentrace 670 System Multichannel Recorder W/oxim.

Edentec Corp., Eden Prairie MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893561 is the FDA 510(k) clearance record for EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM., a class I device, cleared for Edentec Corp. on under FDA product code DSF (Recorder, Paper Chart). FDA records list 18 510(k) clearances for Edentec Corp., from to . As of , FDA records show no recalls naming K893561.

Clearance record

Decision date
Received
(108 days to decision)
Product code
DSF Recorder, Paper Chart
Regulation
21 CFR 870.2810
Device class
Class I
Review panel
Cardiovascular
Applicant
Edentec Corp. 10252 Valley View Rd., Eden Prairie MN
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