510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K781867Substantially Equivalent

Writer, Gemini-3

C-V Monitors Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K781867 is the FDA 510(k) clearance record for WRITER, GEMINI-3, a class I device, cleared for C-V Monitors Corp. on under FDA product code DSF (Recorder, Paper Chart). FDA records list 5 510(k) clearances for C-V Monitors Corp., from to . As of , FDA records show no recalls naming K781867.

Clearance record

Decision date
Received
(63 days to decision)
Product code
DSF Recorder, Paper Chart
Regulation
21 CFR 870.2810
Device class
Class I
Review panel
Cardiovascular
Applicant
C-V Monitors Corp. 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