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
DSA Cable, Transducer And Electrode, Patient, (Including Connector)

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Other Clearances by TRONOMED, INC.

K Number Device Name
K952659 TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM
K853303 LIFELINC LEADWIRE
K853452 LIFE LINC PATIENT CABLE
K841092 HIGH PRESSURE FLEX. CONNECTING TUBING
K792128 STERILE EXTENSION TUBES INDIV. PKG.
K792124 TANDEM ASSEMBLED 3&4 WAY STOPCOCKS
K792127 PLAS. STCK. W/EXTENSION TUBE/STERILE
K792125 3&4 WAY PLASTIC STOPCOCKS, NONSTERILE
K792126 3&4 WAY PLASTIC STERILE STPCKS. PKG.
K771645 ELECTROCARDIOGRAPHIC CABLHS & LEAD WIRE
Search all 12 clearances from TRONOMED, INC. →