FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTROCARDIOGRAPHIC PATIENT CABLES
K Number: K771027
·
Decision Jul 5, 1977
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
101
Applicant Total
12
Review Days
27
Basic Information
- Device Name
- ELECTROCARDIOGRAPHIC PATIENT CABLES
- K Number
- K771027
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2900
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- TRONOMED, INC.
- Date Received
- June 8, 1977
- Decision Date
- July 5, 1977
- Product Code
- DSA
- 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 |
|---|---|---|---|
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | FDA class 2 | Cardiovascular |
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Other Clearances by TRONOMED, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K952659 | TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM | Jan 11, 1996 | Substantially Equivalent |
| K853303 | LIFELINC LEADWIRE | Sep 18, 1985 | Substantially Equivalent |
| K853452 | LIFE LINC PATIENT CABLE | Sep 10, 1985 | Substantially Equivalent |
| K841092 | HIGH PRESSURE FLEX. CONNECTING TUBING | Jul 24, 1985 | Substantially Equivalent |
| K792128 | STERILE EXTENSION TUBES INDIV. PKG. | Jan 16, 1980 | Substantially Equivalent |
| K792124 | TANDEM ASSEMBLED 3&4 WAY STOPCOCKS | Jan 16, 1980 | Substantially Equivalent |
| K792127 | PLAS. STCK. W/EXTENSION TUBE/STERILE | Jan 16, 1980 | Substantially Equivalent |
| K792125 | 3&4 WAY PLASTIC STOPCOCKS, NONSTERILE | Jan 16, 1980 | Substantially Equivalent |
| K792126 | 3&4 WAY PLASTIC STERILE STPCKS. PKG. | Jan 16, 1980 | Substantially Equivalent |
| K771645 | ELECTROCARDIOGRAPHIC CABLHS & LEAD WIRE | Oct 18, 1977 | Substantially Equivalent |