OLYMPUS MEDICAL SYSTEMS CORP.

Address:2951 ISHIKAWA-CHO,HACHIOJI-SHI Tokyo,JP

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Colonoscope and accessories, flexible/rigid (FDF) (3) Endoscope, accessories, narrow band spectrum (NWB) (2) Endoscopic Video Imaging System/Component, Gastroenterology-Urology (FET) (2) Endoscopic video imaging system/component, gastroenterology-urology (FET) (2) Gastroscope and accessories, flexible/rigid (FDS) (2) Laparoscope, general & plastic surgery (GCJ) (2) endoscopic central control unit (ODA) (1) ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES (GEI) (1) System, x-ray, fluoroscopic, non-image-intensified (JAB) (1)

Premarket Exempt

No Yes

Clear

AUTOMATIC LIGHT CONTROL CABLE - 04953170026164 Catalog Number :

Device Description : MAJ-060 AUTO BRIGHTNESS CBL CV-100/200

Device Class : 2

Duns Number: 711789789

Premarket Exempt : No

Product Code : FET

Prescription Use : Yes

Device Count : 1

UPD data transfer cable - 04953170026201 Catalog Number :

Device Description : "MAJ-608 UPD DATA TRANSFER CABLE"

Device Class : 2

Duns Number: 711789789

Premarket Exempt : No

Product Code : FDF, JAB

Prescription Use : Yes

Device Count : 1

FINDER CAP - 04953170026294 Catalog Number :

Device Description : "MAJ-690 CAP(5EA)VIEWFINDER FOR OTV-S6H-1"

Device Class :

Duns Number: 711789789

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 5

Videoscope cable EXERA - 04953170026317 Catalog Number :

Device Description : "MAJ-843 VIDEOSCOPE CABLE FOR T HE CV-160"

Device Class : 2

Duns Number: 711789789

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

KEY BOARD - 04953170026324 Catalog Number :

Device Class : 2

Duns Number: 711789789

Premarket Exempt : No

Product Code : FET

Prescription Use : No

Device Count : 1

MONITOR ADAPTER - 04953170026355 Catalog Number :

Device Description : "MAJ-848 MONITOR CABLE ADAPTER FOR CV-160"

Device Class : 2

Duns Number: 711789789

Premarket Exempt : No

Product Code : FET

Prescription Use : Yes

Device Count : 1

REMOTE CABLE - 04953170026386 Catalog Number :

Device Description : "MAJ-854 REMOTE CABLE CV-160 FOR SVR PRIN"

Device Class : 2

Duns Number: 711789789

Premarket Exempt : No

Product Code : ODA, GCJ

Prescription Use : Yes

Device Count : 1

PRINTER CABLE SET-A - 04953170026461 Catalog Number :

Device Description : "MAJ-884 PRINTER CABLE SET A FOR CV-160"

Device Class : 2

Duns Number: 711789789

Premarket Exempt : No

Product Code : FDS, FDF, NWB

Prescription Use : Yes

Device Count : 1

PRINTER CABLE SET-B - 04953170026478 Catalog Number :

Device Description : "MAJ-885 PRINTER CABLE SET B FOR CV-160"

Device Class : 2

Duns Number: 711789789

Premarket Exempt : No

Product Code : NWB, FDS, FDF

Prescription Use : Yes

Device Count : 1

VTR REMOTE CABLE - 04953170026485 Catalog Number :

Device Class : 2

Duns Number: 711789789

Premarket Exempt : No

Product Code : FET

Prescription Use : No

Device Count : 1

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