FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRACETS SME 5000
K Number: K912450
·
Decision Aug 28, 1991
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
27
Review Days
86
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Basic Information
- Device Name
- TRACETS SME 5000
- K Number
- K912450
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Lectec Corp.
- Date Received
- June 3, 1991
- Decision Date
- August 28, 1991
- Product Code
- DRX
- 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 |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | FDA class 2 | Cardiovascular |
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Other Clearances by Lectec Corp.
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|---|---|---|---|
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| K930258 | TRACET T-6000 | Apr 16, 1993 | Substantially Equivalent |
| K923558 | ECG ELECTRODE | Feb 18, 1993 | Substantially Equivalent |
| K922959 | ISOPORE TAPE | Sep 11, 1992 | Substantially Equivalent |
| K904512 | TRACET AG 4000 | Jan 31, 1991 | Substantially Equivalent |
| K893425 | VITATRACE | Jul 14, 1989 | Substantially Equivalent |
| K884108 | MACROPORE MEDICAL/SURGICAL PAPER TAPE | Nov 10, 1988 | Substantially Equivalent for Some Indications |
| K882216 | SYNCOR (R) MODEL S-801 ECG ELECTRODE | Jul 20, 1988 | Substantially Equivalent |
| K881871 | SPARE MS 700 TENS ELECTRODE | Jun 16, 1988 | Substantially Equivalent |