510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K870857Substantially Equivalent

Abcom 1 Cardiac Output Monitor

Applied Biometrics, Inc., Minnetonka MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870857 is the FDA 510(k) clearance record for ABCOM 1 CARDIAC OUTPUT MONITOR, a class II device, cleared for Applied Biometrics, Inc. on under FDA product code JOP (Transducer, Ultrasonic). FDA records list 3 510(k) clearances for Applied Biometrics, Inc., from to . As of , FDA records show no recalls naming K870857.

Clearance record

Decision date
Received
(258 days to decision)
Product code
JOP Transducer, Ultrasonic
Regulation
21 CFR 870.2880
Device class
Class II
Review panel
Cardiovascular
Applicant
Applied Biometrics, Inc. 14873 Deveau Pl., Minnetonka MN
Third party review
No

Clearances, product code JOP

Trailing 12 months

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

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