3000 Physiological Monitor
FDA 510(k) K880301 · Datascope Corp.
510(k) numberK880301
Submission
- Device name
- 3000 Physiological Monitor
- Applicant
- Datascope Corp.
Paramus, NJ, US - Received
- January 25, 1988
- Decision date
- August 19, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1435
- Specialty
- Cardiovascular
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| K133074 | Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon Catheters and AccessoriesDSP · Special | 12/12/2013SE |
| K071805 | Netguard Automated Clinician Alert System, Model 0998-00-1600-XXDSI · Abbreviated | 09/25/2007SE |
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Questions and answers
When was 3000 Physiological Monitor cleared by the FDA?
3000 Physiological Monitor (K880301) received a 510(k) decision of Substantially Equivalent on August 19, 1988, 207 days after the submission was received.
What is the product code of K880301?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.