Spectrum Patient Monitor, Model 0998-00-0500-XXXXX
FDA 510(k) K031849 · Datascope Corp.
510(k) numberK031849
Submission
- Device name
- Spectrum Patient Monitor, Model 0998-00-0500-XXXXX
- Applicant
- Datascope Corp.
Mahwh, NJ, US - Received
- June 16, 2003
- Decision date
- September 9, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
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Questions and answers
When was Spectrum Patient Monitor, Model 0998-00-0500-XXXXX cleared by the FDA?
Spectrum Patient Monitor, Model 0998-00-0500-XXXXX (K031849) received a 510(k) decision of Substantially Equivalent on September 9, 2003, 85 days after the submission was received.
What is the product code of K031849?
The FDA product code is MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.1025.