Medical Device Manufacturer · US , South Burlington , VT

Softheart, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1992
3
Total
3
Cleared
0
Denied

FDA 510(k) Regulatory Record - Softheart, Inc. Cardiovascular ✕

3 devices
1-3 of 3
Cleared Sep 22, 1993
ON-LINE ANALYSIS SYSTEM
K930639 · DQK
Cardiovascular · 225d
Cleared Nov 20, 1992
OFF-LINE ANALYSIS SYSTEM
K921216 · DQK
Cardiovascular · 252d
Cleared Feb 26, 1992
CATHWRITER(TM)
K914105 · DQK
Cardiovascular · 166d
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