Medical Device Manufacturer · US , Orange , CA

Fluke Biomedical - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2008

Recent clearances: ESA615, ESA620 ELECTRICAL SAFETY ANALYZER, PROSIM 4, PROSIM 6, PROSIM 8

View 6 510(k) Devices ↓

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Fluke Biomedical Cardiovascular ✕

6 devices

1-6 of 6

Cleared Jan 25, 2013

Cardiovascular · 213d

Cleared Oct 11, 2012

ESA620 ELECTRICAL SAFETY ANALYZER

Cardiovascular · 121d

Cleared Sep 02, 2011

PROSIM 4, PROSIM 6, PROSIM 8

Cardiovascular · 199d

Cleared Apr 13, 2011

MPS450 MULTIPARAMETER SIMULATOR

Cardiovascular · 149d

Cleared Dec 24, 2008

IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS

Cardiovascular · 41d

Cleared Jan 28, 2008

IMPULSE 6000D/7000DP

Cardiovascular · 180d