Sirecust 420 Patient Dialog Monitor
FDA 510(k) K851400 · Siemens Medical Solutions USA, Inc.
510(k) numberK851400
Submission
- Device name
- Sirecust 420 Patient Dialog Monitor
- Applicant
- Siemens Medical Solutions USA, Inc.
Iselin, NJ, US - Received
- April 9, 1985
- Decision date
- June 26, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXJ – Display, Cathode-Ray Tube, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2450
- Specialty
- Cardiovascular
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Questions and answers
When was Sirecust 420 Patient Dialog Monitor cleared by the FDA?
Sirecust 420 Patient Dialog Monitor (K851400) received a 510(k) decision of Substantially Equivalent on June 26, 1985, 78 days after the submission was received.
What is the product code of K851400?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.