FDA 510(k)
Substantially Equivalent
🇺🇸 United States
KLEENIT BY QMED
K Number: K843559
·
Decision Oct 24, 1984
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
11
Review Days
44
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Basic Information
- Device Name
- KLEENIT BY QMED
- K Number
- K843559
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Qmed, Inc.
- Date Received
- September 10, 1984
- Decision Date
- October 24, 1984
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
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 |
| K861437 | QMED SYSTEM 2150 | May 20, 1986 | Substantially Equivalent |
| K841172 | MONITOR ONE | Jul 27, 1984 | Substantially Equivalent |
| K840465 | Q-MED ELECTRODE | Jun 19, 1984 | Substantially Equivalent |