510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800096Substantially Equivalent

Ambivason Dr-200

Kt Medical, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800096 is the FDA 510(k) clearance record for AMBIVASON DR-200, a class II device, cleared for Kt Medical, Inc. on under FDA product code JAF (Monitor, Ultrasonic, Nonfetal). FDA records list 13 510(k) clearances for Kt Medical, Inc., from to . As of , FDA records show no recalls naming K800096.

Clearance record

Decision date
Received
(28 days to decision)
Product code
JAF Monitor, Ultrasonic, Nonfetal
Regulation
21 CFR 892.1540
Device class
Class II
Review panel
Radiology
Applicant
Kt Medical, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JAF

Trailing 12 months

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

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