FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIFE LINC PATIENT CABLE
K Number: K853452
·
Decision Sep 10, 1985
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
174
Applicant Total
12
Review Days
25
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Basic Information
- Device Name
- LIFE LINC PATIENT CABLE
- K Number
- K853452
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Tronomed, Inc.
- Date Received
- August 16, 1985
- Decision Date
- September 10, 1985
- Product Code
- BZQ
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BZQ | Monitor, Breathing Frequency | FDA class 2 | Anesthesiology |
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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 |
| K841092 | HIGH PRESSURE FLEX. CONNECTING TUBING | Jul 24, 1985 | Substantially Equivalent |
| K792125 | 3&4 WAY PLASTIC STOPCOCKS, NONSTERILE | Jan 16, 1980 | 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 |
| K792126 | 3&4 WAY PLASTIC STERILE STPCKS. PKG. | Jan 16, 1980 | Substantially Equivalent |
| K792127 | PLAS. STCK. W/EXTENSION TUBE/STERILE | Jan 16, 1980 | Substantially Equivalent |
| K771645 | ELECTROCARDIOGRAPHIC CABLHS & LEAD WIRE | Oct 18, 1977 | Substantially Equivalent |
| K771027 | ELECTROCARDIOGRAPHIC PATIENT CABLES | Jul 5, 1977 | Substantially Equivalent |