CARDIOVIEW32 REVIEW MODULE— 510(k) K083749

Substantially Equivalent

Qrs Diagnostic, LLC

FDA 510(k) clearance K083749 for CARDIOVIEW32 REVIEW MODULE, Substantially Equivalent on 2009-03-10. Applicant: Qrs Diagnostic, LLC.

Clearance details

Applicant: Qrs Diagnostic, LLC
Product code: Code LOS
Advisory panel: Unknown
Date received: 2008-12-17
Decision date: 2009-03-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LOS

K090895 — EKG-PLUS II SOFTWARE2009-08-26
K073376 — PHILIPS ECG ALGORITHM2008-04-11
K023034 — CARDIOTOUCH-30002002-11-14
K011328 — CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH2001-11-21
K993616 — CARDIO-CARD INTERPRETATION SYSTEM I2000-04-10

More clearances from Qrs Diagnostic, LLC

K073630 — MODIFICATION TO: BPCARD, MODEL Z-7000-07002008-01-11
K031964 — BPCARD2003-09-05
K030535 — EKGCARD SYSTEM2003-06-11
K001278 — SENSAIRE DIAGNOSTIC SPIROMETER2000-11-29
K001995 — SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER2000-09-08

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