FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QMED SYSTEM 2150
K Number: K861437
·
Decision May 20, 1986
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
176
Applicant Total
11
Review Days
33
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Basic Information
- Device Name
- QMED SYSTEM 2150
- K Number
- K861437
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1435
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Qmed, Inc.
- Date Received
- April 17, 1986
- Decision Date
- May 20, 1986
- 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 Qmed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972991 | MONITOR ONE NDX | Dec 3, 1998 | Substantially Equivalent |
| K932109 | PROFILOMAT | Dec 3, 1993 | Substantially Equivalent |
| K921476 | INTERP-1000 | Oct 21, 1992 | Substantially Equivalent |
| K897121 | QEKG ELECTROCARDIOGRAPH | Apr 30, 1990 | Substantially Equivalent |
| K873591 | A.R.M. (ASPEN RETURN MONITOR) | Sep 30, 1987 | Substantially Equivalent |
| K862377 | QMED SELF ADHERING ELECTRODE | Sep 26, 1986 | Substantially Equivalent |
| K863091 | BICORD BY QMED | Aug 29, 1986 | Substantially Equivalent |
| K843559 | KLEENIT BY QMED | Oct 24, 1984 | Substantially Equivalent |
| K841172 | MONITOR ONE | Jul 27, 1984 | Substantially Equivalent |
| K840465 | Q-MED ELECTRODE | Jun 19, 1984 | Substantially Equivalent |