510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K860790Substantially Equivalent

Biomecca Caretaker 1000 & 2000

Biomecca Australia, Ltd., Marrickville, Sydney, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860790 is the FDA 510(k) clearance record for BIOMECCA CARETAKER 1000 & 2000, a class II device, cleared for Biomecca Australia , Ltd. on under FDA product code DPS (Electrocardiograph). FDA records list 2 510(k) clearances for Biomecca Australia , Ltd., from to . As of , FDA records show no recalls naming K860790.

Clearance record

Decision date
Received
(65 days to decision)
Product code
DPS Electrocardiograph
Regulation
21 CFR 870.2340
Device class
Class II
Review panel
Cardiovascular
Applicant
Biomecca Australia , Ltd. 48a Chapel St., Marrickville, Sydney, AU
Third party review
No

Clearances, product code DPS

Trailing 12 months
6 clearances under product code DPS in the twelve months to October 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DPS, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20262
October 20260