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FDA 510(k)

SELDIX 325 TWO PULSE GENERATOR/CONTROL

K-Number: K883154 · 1988-09-06

ApplicantBay X-Ray, Inc.
Decision Date1988-09-06
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SELDIX 325 TWO PULSE GENERATOR/CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Bay X-Ray, Inc.. It received FDA 510(k) clearance on 1988-09-06 under 510(k) number K883154. The device is classified under product code IZO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SELDIX 325 TWO PULSE GENERATOR/CONTROL?

SELDIX 325 TWO PULSE GENERATOR/CONTROL is a medical device that received FDA 510(k) clearance on 1988-09-06. The listed applicant is Bay X-Ray, Inc.. The 510(k) number is K883154.

When did SELDIX 325 TWO PULSE GENERATOR/CONTROL receive FDA 510(k) clearance?

SELDIX 325 TWO PULSE GENERATOR/CONTROL received FDA 510(k) clearance on 1988-09-06, under 510(k) number K883154.

Who is the listed applicant for SELDIX 325 TWO PULSE GENERATOR/CONTROL?

The FDA 510(k) record lists Bay X-Ray, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SELDIX 325 TWO PULSE GENERATOR/CONTROL?

The FDA product code for SELDIX 325 TWO PULSE GENERATOR/CONTROL is IZO.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bay X-Ray, 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.

K883161HIMOBILIX 2NK883160CATAPULT BUCKY (KATAPULT BLENDA)K883155RASTIX X-RAY TABLEK883153UNDISTAT WITH EXPLORATOR 35 (UCS 35E)K883162TELESTATIX X-RAY TABLE

Related Devices (Code: IZO)

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.

K954666MPH50, MPH65, AND MPH80GE Medical SystemsK953582HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATORVarian Canada, Inc.K953831N 800 HFNucletron-Oldelft Corp.K952822SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150GShimadzu Corp.K952265MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATORControl-X, Inc.K950883POLYDOROS SX 65 AND 80Siemens Medical Solutions USA, Inc.

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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