Sams 8000 Cardioplegia Monitor
FDA 510(k) K960916 · 3M Health Care, Sarns
510(k) numberK960916
Submission
- Device name
- Sams 8000 Cardioplegia Monitor
- Applicant
- 3M Health Care, Sarns
Ann Arbor, MI, US - Received
- March 6, 1996
- Decision date
- June 4, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSJ – Alarm, Blood-Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1100
- Specialty
- Cardiovascular
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Questions and answers
When was Sams 8000 Cardioplegia Monitor cleared by the FDA?
Sams 8000 Cardioplegia Monitor (K960916) received a 510(k) decision of Substantially Equivalent on June 4, 1996, 90 days after the submission was received.
What is the product code of K960916?
The FDA product code is DSJ – Alarm, Blood-Pressure, a Class II (moderate risk) device regulated under 21 CFR 870.1100.