FDA 510(k)

SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION

K-Number: K875378 · 1988-11-16

ApplicantShimadzu Precision Instruments, Inc.

Decision Date1988-11-16

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION 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 1988-11-16 under 510(k) number K875378. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION?

SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION is a medical device that received FDA 510(k) clearance on 1988-11-16. The listed applicant is Shimadzu Precision Instruments, Inc.. The 510(k) number is K875378.

When did SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION receive FDA 510(k) clearance?

SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION received FDA 510(k) clearance on 1988-11-16, under 510(k) number K875378.

Who is the listed applicant for SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION?

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 SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION?

The FDA product code for SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION is KPS.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Shimadzu Precision Instruments, Inc. as applicant

K940294SHIMADZU MOBILE X-RAY SYSTEMS K890913SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT K884598SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200 K884477SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B K882311SHIMADZU LATERAL C-ARM MH-31 K881674SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TC

View all 23 devices →

Related Devices (Code: KPS)

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.