FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413
K Number: K000660
·
Decision Mar 28, 2000
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
83
Applicant Total
27
Review Days
29
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Basic Information
- Device Name
- ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413
- K Number
- K000660
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.5550
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Data Electronics
- Date Received
- February 28, 2000
- Decision Date
- March 28, 2000
- Product Code
- DRO
- 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 |
|---|---|---|---|
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | FDA class 2 | Cardiovascular |
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Other Clearances by Medical Data Electronics
| K Number | Device Name | ||
|---|---|---|---|
| K014294 | MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414 | Jan 25, 2002 | Substantially Equivalent |
| K012336 | MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500 | Oct 3, 2001 | Substantially Equivalent |
| K992413 | ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR | Aug 19, 1999 | Substantially Equivalent |
| K992411 | ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR | Aug 18, 1999 | Substantially Equivalent |
| K982104 | ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500 | Nov 25, 1998 | Substantially Equivalent |
| K970763 | MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR | Jul 14, 1997 | Substantially Equivalent |
| K970011 | ESCORT II CLINICAL THERMOMETRY MODULE (CTM) | Jul 9, 1997 | Substantially Equivalent |
| K970012 | ESCORT LINK CENTRAL STATION MONITOR | Jun 26, 1997 | Substantially Equivalent |
| K961138 | ESORT II + 400 SERIES MONITOR | Dec 10, 1996 | Substantially Equivalent |
| K943256 | CARDIAC OUTPUT OPTION 39 | Dec 15, 1994 | Substantially Equivalent |