PACEART WRIST ELECTRODES— 510(k) K960721

Name: FDA 510(k) clearance K960721
Creator: U.S. Food and Drug Administration
Published: 1996-07-18

Substantially Equivalent

Paceart, Inc.

FDA 510(k) clearance K960721 for PACEART WRIST ELECTRODES, Substantially Equivalent on 1996-07-18. Applicant: Paceart, Inc.. Device class: 2.

Clearance details

Applicant: Paceart, Inc.
Product code: Code DRX
Device class: Class 2
Regulation: 21 CFR 870.2360
Advisory panel: Cardiovascular
Date received: 1996-02-22
Decision date: 1996-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayne, NJ, US

Download summary PDF View on FDA.gov ↗

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K101685 — IP-SET2010-07-01

More clearances from Paceart, Inc.

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K012407 — PACEART TX3 CARDIAC EVENT RECORDER2001-08-14
K982090 — PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM1999-01-26
K973141 — HEART ACCESS PLUS CARDIAC EVENT RECORDER1997-11-12
K952065 — PACEART CARDIOVOICE1996-01-16
K931296 — PACEART CARDIOPHONE1993-10-01

Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.