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Found 14 results
510(k) Data Aggregation
K Number
K120234Device Name
EZONO 3000
Manufacturer
LIFE-TECH, INC.
Date Cleared
2012-04-19
(85 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
LIFE-TECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the eZono 3000, as defined by FDA guidance documents, are: Ophthalmic, Musculo-skeletal (Conventional), Fetal (as enumerated in the IFU Tables), Musculo-skeletal (Superficial), Abdominal, Retroperitoneum, Pediatric, Female reproductive system and foetus, Small Organ (breast, thyroid, testicle), Cardiac (Adult), Invasive diagnostic or therapeutic procedures, Cardiac (Pediatric), Peripheral vessel.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal, Abdominal, Intra-operative (Specify), Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (e.g. testicles, lymph nodes, thyroid), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Intravascular, Invasive diagnostic or therapeutic procedures (e.g. biopsies, punctures, free fluid detection, regional anesthesia, vascular access), Superficial structures & pathologies (incl. Lungs), Cardiac Adult, Cardiac Pediatric, Intravascular (Cardiac), Trans-esoph. (Cardiac), Intra-cardiac, Other (Specify), Peripheral vessel.
Device Description
eZono 3000
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K Number
K111355Device Name
ECHOBRIGHT
Manufacturer
LIFE-TECH, INC.
Date Cleared
2011-09-16
(123 days)
Product Code
CAZ
Regulation Number
868.5140Why did this record match?
Applicant Name (Manufacturer) :
LIFE-TECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K102813Device Name
EZONO 3000
Manufacturer
LIFE-TECH, INC.
Date Cleared
2011-06-30
(275 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
LIFE-TECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K102007Device Name
PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC,
Manufacturer
LIFE-TECH, INC.
Date Cleared
2010-12-22
(159 days)
Product Code
CAZ
Regulation Number
868.5140Why did this record match?
Applicant Name (Manufacturer) :
LIFE-TECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The interestly and analogs'is vila lions For Ose. The 1977 her in and analgesia vila blockade of peripheral nerves.
Device Description
Not Found
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K Number
K093662Device Name
ECHOBRIGHT
Manufacturer
LIFE-TECH, INC.
Date Cleared
2010-06-24
(211 days)
Product Code
CAZ
Regulation Number
868.5140Why did this record match?
Applicant Name (Manufacturer) :
LIFE-TECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Echobright Kit is for regional anestheria and analgesia via blockade of peripheral nerves.
Device Description
Not Found
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K Number
K093485Device Name
VESISCAN
Manufacturer
LIFE-TECH, INC.
Date Cleared
2010-03-16
(127 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
LIFE-TECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vesiscan is used to measure bladder volume.
Device Description
Not Found
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K Number
K082772Device Name
STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC19100, SPC19150, SPC18050,SPC18100,SPC18150
Manufacturer
LIFE-TECH, INC.
Date Cleared
2009-02-09
(140 days)
Product Code
BSP
Regulation Number
868.5150Why did this record match?
Applicant Name (Manufacturer) :
LIFE-TECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Shinfra is weed to administer peripheral nerve blocks,
Device Description
Not Found
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K Number
K082056Device Name
ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1
Manufacturer
LIFE-TECH, INC.
Date Cleared
2008-11-07
(109 days)
Product Code
FFX
Regulation Number
876.1725Why did this record match?
Applicant Name (Manufacturer) :
LIFE-TECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ARM-1 is interdad to enable the Urolab equipment to measure and record the functioning of a patient's anorectal. function.
Device Description
Ano-Rectal Manometry Option (ARM-1)
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K Number
K082923Device Name
PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C
Manufacturer
LIFE-TECH, INC.
Date Cleared
2008-10-24
(23 days)
Product Code
CAC
Regulation Number
868.5830Why did this record match?
Applicant Name (Manufacturer) :
LIFE-TECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Prolong is for local anesthesia and analgesia via blockade of peripheral nerves.
Device Description
Not Found
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K Number
K081864Device Name
PROLONG
Manufacturer
LIFE-TECH, INC.
Date Cleared
2008-09-25
(86 days)
Product Code
BSP
Regulation Number
868.5150Why did this record match?
Applicant Name (Manufacturer) :
LIFE-TECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the ProLong Centinuous Nerve Block set is for prolonged regional anesthesia and analgesia via blockade of peripheral nerves.
Device Description
Not Found
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