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Found 4 results
510(k) Data Aggregation
K Number
K102718Device Name
DIGITAL THERMOMETER; DIGITAL THERMOMETER
Manufacturer
INTERNATIONAL REGULATORY CONSULTANTS, LLC (IRC)
Date Cleared
2010-12-13
(83 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL REGULATORY CONSULTANTS, LLC (IRC)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To measure the human body temperature in regular mode orally, rectally or underarm. The devices are reusable for clinical or home use on people of all ages.
Device Description
The GF-MT501 and GF-MT502 digital thermometer comprise of a thermistor for measuring sensor, a reference resistor for comparison of the temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts. The thermometers use a DC 1.5V battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays ' in LCD display.
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K Number
K981591Device Name
VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT
Manufacturer
INTERNATIONAL REGULATORY CONSULTANTS
Date Cleared
1998-10-09
(158 days)
Product Code
FAD
Regulation Number
876.4620Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL REGULATORY CONSULTANTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Both the VORTEK and BIOSOFT versions of the ureteral double loop stent are intended for the exact same use as the current silicone ureteral double loop stent. The ureteral double loop stent are intended for drainage of the upper urinary tract where indicated such as in the case of ureteral obstruction, fistula, calculus debris/fragmentation, tumor, etc. The "flush" ureteric configuration with certain models (reference numbers) is intended to flush the lithiasis to the kidney before ESWL.
Device Description
VORTEK® and BIOSOFT® Ureteral Double Loop Stents
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K Number
K971347Device Name
MEDISURF
Manufacturer
INTERNATIONAL REGULATORY CONSULTANTS
Date Cleared
1997-07-03
(84 days)
Product Code
LMD
Regulation Number
892.2020Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL REGULATORY CONSULTANTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MediSurf is intended to facilitate access to clinical images and information in distributed locations. Along with image processing capabilities, MediSurf can be used by radiologists for on-call teleradiology over "intranets", Internet, direct or dial-up lines, and for providing second opinion services. It can also be used by physicians for enhanced interpretation of cases through the inclusion of images in imaging related reports and in patient records in general. Similarly it can be used by healthcare organization staff for facilitated access to clinical images throughout the healthcare organization.
Device Description
The MediSurf server is an access engine to healthcare information. MediSurf provides its end-users with easy access to DICOM devices and networks for the retrieval of images in full diagnostic quality using adaptive progressive compression for efficient transfer over different communication links. The server also provides the user with the software applets needed to display, process, store, and send the retrieved clinical data.
The MediSurf server is based on off-the-shelf UNIX based computer that complies with the accepted international standards for computer systems. The system also comprises software developed and validated by Algotec Systems Ltd..
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K Number
K962614Device Name
SHIFA STERILE DISPOSABLE SYRINGES
Manufacturer
INTERNATIONAL REGULATORY CONSULTANTS
Date Cleared
1996-09-06
(65 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL REGULATORY CONSULTANTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Shifa Syringes are intended for injection of
Device Description
Shifa Syringes are sterile disposable medical piston syringes consisting of barrel with luer-lock or slip-lock nozzle, gasket, and a needle. They are sold with or without needles. The barrel, and plunger are polypropylene, the gasket is natural rubber, and the needle is stainless steel.
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