FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMS-2000R RESTING ELECTROCARDIOGRAPHIC SYSTEM
K Number: K870934
·
Decision May 6, 1987
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
176
Applicant Total
5
Review Days
58
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Basic Information
- Device Name
- IMS-2000R RESTING ELECTROCARDIOGRAPHIC SYSTEM
- K Number
- K870934
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1435
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Integrated Medical Systems, Inc.
- Date Received
- March 9, 1987
- Decision Date
- May 6, 1987
- Product Code
- DXG
- 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 |
|---|---|---|---|
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | FDA class 2 | Cardiovascular |
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Other Clearances by Integrated Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K082256 | LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE | Sep 26, 2008 | Substantially Equivalent |
| K902682 | STICK-GARD STERILE CAP | Sep 26, 1990 | Substantially Equivalent |
| K895414 | MULTIMED (TM) PULMONARY FUNCTION TESTING SYSTEM | Feb 12, 1990 | Substantially Equivalent |
| K871659 | IMS-2000S STRESS MONITOR | May 28, 1987 | Substantially Equivalent |