FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ESCORT 300 SERIES
K Number: K911665
·
Decision Aug 29, 1991
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
165
Applicant Total
27
Review Days
139
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Basic Information
- Device Name
- ESCORT 300 SERIES
- K Number
- K911665
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Medical Data Electronics
- Date Received
- April 12, 1991
- Decision Date
- August 29, 1991
- Product Code
- LDD
- 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 |
|---|---|---|---|
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 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 |
| K000660 | ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413 | Mar 28, 2000 | 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 |