Medical Device Manufacturer · US , Plymouth , MN

Qrs Diagnostic, LLC - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 1998

Recent clearances: CARDIOVIEW32 REVIEW MODULE, MODIFICATION TO: BPCARD, MODEL Z-7000-0700, BPCARD

View 7 510(k) Devices ↓

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Qrs Diagnostic, LLC Anesthesiology ✕

3 devices

1-3 of 3

Cleared Nov 29, 2000

SENSAIRE DIAGNOSTIC SPIROMETER

Anesthesiology · 222d

Cleared Sep 08, 2000

SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER

Anesthesiology · 70d

Cleared Oct 28, 1998

Anesthesiology · 433d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 07, 2026