FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GERARD MEDICAL ELECTRODE TESTER
K Number: K813358
·
Decision Dec 29, 1981
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
10
Applicant Total
8
Review Days
29
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Basic Information
- Device Name
- GERARD MEDICAL ELECTRODE TESTER
- K Number
- K813358
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2370
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Gerard Medical Enterprises, Inc.
- Date Received
- November 30, 1981
- Decision Date
- December 29, 1981
- Product Code
- KRC
- 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 |
|---|---|---|---|
| KRC | Tester, Electrode, Surface, Electrocardiographic | FDA class 2 | Cardiovascular |
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Other Clearances by Gerard Medical Enterprises, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954258 | TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION) | May 24, 1996 | Substantially Equivalent |
| K945250 | TRIMPORT | Mar 7, 1995 | Substantially Equivalent |
| K942623 | TRIMPORT | Aug 23, 1994 | Substantially Equivalent |
| K922147 | DUAL PLASTIC VASCULAR ACCESS SYSTEM | Dec 4, 1992 | Substantially Equivalent |
| K913114 | TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT | Jan 2, 1992 | Unknown |
| K912111 | MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE | Oct 8, 1991 | Substantially Equivalent |
| K903364 | GERARD MEDICAL, INC. TRIM-PORT | Oct 31, 1990 | Unknown |