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

Laparoscope, general & plastic surgery (GCJ) (2) Endoscope, accessories, narrow band spectrum (NWB) (2) Colonoscope and accessories, flexible/rigid (FDF) (2) System, imaging, pulsed echo, ultrasonic (IYO) (2) Gastroscope and accessories, flexible/rigid (FDS) (2) Transducer, ultrasonic, diagnostic (ITX) (1) Endoscopic video imaging system/component, gastroenterology-urology (FET) (1) Lithotriptor, Ultrasonic (FEO) (1) Lithotriptor, ultrasonic (FEO) (1) BRONCHOSCOPE (FLEXIBLE OR RIGID) (EOQ) (1)

Premarket Exempt

No Yes

Clear

PUMP REMOTE CABLE - 04953170026492 Catalog Number :

Device Description : "MAJ-920 OFP RMT CBL-CV-160 COMPAT W/ EW"

Device Class : 2

Duns Number: 711789789

Premarket Exempt : No

Product Code : ITX, IYO

Prescription Use : Yes

Device Count : 1

White cap set - 04953170026553 Catalog Number :

Device Description : "MAJ-941 WHITE CAP SET"

Device Class : 2

Duns Number: 711789789

Premarket Exempt : No

Product Code : FDS, NWB, FDF

Prescription Use : Yes

Device Count : 1

WHITE CAP HOLDER - 04953170026584 Catalog Number :

Device Description : "MAJ-960 WHITE CAP HOLDER"

Device Class : 2

Duns Number: 711789789

Premarket Exempt : No

Product Code : FDF, NWB, FDS

Prescription Use : Yes

Device Count : 1

MONITOR CABLE - 04953170026591 Catalog Number :

Device Description : "MAJ-970 MONITOR CABLE (4M) FOR CV-160"

Device Class : 2

Duns Number: 711789789

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Y/C cable - 04953170026669 Catalog Number :

Device Description : "MB-631 ISOLATION TRANSFORMER"

Device Class : 2

Duns Number: 711789789

Premarket Exempt : No

Product Code : FET

Prescription Use : Yes

Device Count : 1

BNC Cable - 04953170026676 Catalog Number :

Device Description : "MB-672 BNC printer cable for EU-M30S"

Device Class : 2

Duns Number: 711789789

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

BNC Cable - 04953170026690 Catalog Number :

Device Description : "MB-677 BNC CABLE"

Device Class : 2

Duns Number: 711789789

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

RGB Video Cable(B) - 04953170026706 Catalog Number :

Device Class : 2

Duns Number: 711789789

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Suction Tube - 04953170026737 Catalog Number :

Device Description : "MB-721 SUCTION TUBE FOR LUS"

Device Class : 2

Duns Number: 711789789

Premarket Exempt : No

Product Code : FEO

Prescription Use : Yes

Device Count : 1

Probe uncologging rod - 04953170026782 Catalog Number :

Device Class : 2

Duns Number: 711789789

Premarket Exempt : No

Product Code : FEO

Prescription Use : No

Device Count : 1

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