FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)
K Number: K013533
·
Decision Jan 18, 2002
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
190
Applicant Total
13
Review Days
87
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Basic Information
- Device Name
- EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)
- K Number
- K013533
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2910
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- General Devices
- Date Received
- October 23, 2001
- Decision Date
- January 18, 2002
- Product Code
- DRG
- 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 |
|---|---|---|---|
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | FDA class 2 | Cardiovascular |
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Other Clearances by General Devices
| K Number | Device Name | ||
|---|---|---|---|
| K002089 | ROSETTA-LT/ROSETTA-RX | Nov 21, 2000 | Substantially Equivalent |
| K993202 | EIM-107 PREP-CHECK | Dec 17, 1999 | Substantially Equivalent |
| K940009 | GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300 | Apr 14, 1995 | Substantially Equivalent |
| K935839 | GEMSCOM SERIES 5000, | Nov 10, 1994 | Substantially Equivalent |
| K921929 | GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION) | Sep 18, 1992 | Substantially Equivalent |
| K914889 | GEMSCOM SERIES 3000 | Mar 4, 1992 | Substantially Equivalent |
| K912008 | TRU-VIEW MULTI-CHANNEL DISPLAY | Oct 9, 1991 | Substantially Equivalent |
| K896153 | MODIFIED DR-2C/PMC 100 | Jan 19, 1990 | Substantially Equivalent |
| K862596 | DR-2C (MODIFICATION) | Sep 26, 1986 | Substantially Equivalent |
| K844650 | DR-2C | Jan 22, 1985 | Substantially Equivalent |