510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001081Substantially Equivalent

Bioz.pc Hemodynamic Monitor Model Bz-500/Bz-501; Bioz.pc User Software Installation Kit Model Bz-810

Cardiodynamics International Corp., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001081 is the FDA 510(k) clearance record for BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810, a class II device, cleared for Cardiodynamics International Corp. on under FDA product code DSB (Plethysmograph, Impedance). FDA records list 11 510(k) clearances for Cardiodynamics International Corp., from to . As of , FDA records show no recalls naming K001081.

Clearance record

Decision date
Received
(87 days to decision)
Product code
DSB Plethysmograph, Impedance
Regulation
21 CFR 870.2770
Device class
Class II
Review panel
Cardiovascular
Applicant
Cardiodynamics International Corp. 6175 Nancy Ridge Dr., #300, San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code DSB

Trailing 12 months
2 clearances under product code DSB in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSB, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260