FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor
K Number: K150030
·
Decision Mar 16, 2015
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
424
Applicant Total
68
Review Days
67
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Basic Information
- Device Name
- Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor
- K Number
- K150030
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fukuda Denshi USA, Inc.
- Date Received
- January 8, 2015
- Decision Date
- March 16, 2015
- Product Code
- MHX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
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Other Clearances by Fukuda Denshi USA, Inc.
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|---|---|---|---|
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| K112521 | FUKUDA DENSHI VASERA MODEL VS-1500 | Dec 21, 2011 | Substantially Equivalent |
| K103134 | FUKUDA DENSHI | Mar 11, 2011 | Substantially Equivalent |
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| K082656 | MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT | Sep 30, 2008 | Substantially Equivalent |
| K081891 | FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR | Aug 29, 2008 | Substantially Equivalent |
| K050363 | FUKUDA DENSHI MODEL UF-850XTD | Feb 17, 2005 | Substantially Equivalent |
| K033711 | FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM | Jun 3, 2004 | Substantially Equivalent |
| K040246 | FUKUDA DENSHI DYNASCOPE MODEL DS-7141 PORTABLE PATIENT MONITOR | May 26, 2004 | Substantially Equivalent |