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FDA 510(k)

SHIMADZU CEREBRAL ANGIOGRAPHIC UNIT ER-100A

K-Number: K875379 · 1988-02-12

ApplicantShimadzu Precision Instruments, Inc.
Decision Date1988-02-12
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SHIMADZU CEREBRAL ANGIOGRAPHIC UNIT ER-100A is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Precision Instruments, Inc.. It received FDA 510(k) clearance on 1988-02-12 under 510(k) number K875379. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHIMADZU CEREBRAL ANGIOGRAPHIC UNIT ER-100A?

SHIMADZU CEREBRAL ANGIOGRAPHIC UNIT ER-100A is a medical device that received FDA 510(k) clearance on 1988-02-12. The listed applicant is Shimadzu Precision Instruments, Inc.. The 510(k) number is K875379.

When did SHIMADZU CEREBRAL ANGIOGRAPHIC UNIT ER-100A receive FDA 510(k) clearance?

SHIMADZU CEREBRAL ANGIOGRAPHIC UNIT ER-100A received FDA 510(k) clearance on 1988-02-12, under 510(k) number K875379.

Who is the listed applicant for SHIMADZU CEREBRAL ANGIOGRAPHIC UNIT ER-100A?

The FDA 510(k) record lists Shimadzu Precision Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHIMADZU CEREBRAL ANGIOGRAPHIC UNIT ER-100A?

The FDA product code for SHIMADZU CEREBRAL ANGIOGRAPHIC UNIT ER-100A is IZI.

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Other records listing Shimadzu Precision Instruments, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K940294SHIMADZU MOBILE X-RAY SYSTEMSK890913SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENTK884598SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200K884477SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150BK875378SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSIONK882311SHIMADZU LATERAL C-ARM MH-31

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Related Devices (Code: IZI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker EndoscopyK253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage CorporationK243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbHK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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