Labsystem III Ep Laboratory W/Windows Platform & Windows Ep Software Version 1.0
FDA 510(k) K031000 · C.R. Bard, Inc.
510(k) numberK031000
Submission
- Device name
- Labsystem III Ep Laboratory W/Windows Platform & Windows Ep Software Version 1.0
- Applicant
- C.R. Bard, Inc.
Lowell, MA, US - Received
- March 31, 2003
- Decision date
- June 3, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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Questions and answers
When was Labsystem III Ep Laboratory W/Windows Platform & Windows Ep Software Version 1.0 cleared by the FDA?
Labsystem III Ep Laboratory W/Windows Platform & Windows Ep Software Version 1.0 (K031000) received a 510(k) decision of Substantially Equivalent on June 3, 2003, 64 days after the submission was received.
What is the product code of K031000?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.