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FDA 510(k)

DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR

K-Number: K972130 · 1997-10-09

ApplicantFairmontmedical
Decision Date1997-10-09
Product CodeIZJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR is the device name listed in this FDA 510(k) record. The listed applicant is Fairmontmedical. It received FDA 510(k) clearance on 1997-10-09 under 510(k) number K972130. The device is classified under product code IZJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR?

DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR is a medical device that received FDA 510(k) clearance on 1997-10-09. The listed applicant is Fairmontmedical. The 510(k) number is K972130.

When did DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR receive FDA 510(k) clearance?

DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR received FDA 510(k) clearance on 1997-10-09, under 510(k) number K972130.

Who is the listed applicant for DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR?

The FDA 510(k) record lists Fairmontmedical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR?

The FDA product code for DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR is IZJ.

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

Related Devices (Code: IZJ)

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.

K024085CCD CAMERA, MODEL PKP-06000-000Perkins Electronics Co.K945580DSP OPTIONPhilips Medical Systems (Cleveland), Inc.K920793PHILIPS DSI SYSTEM RELEASE 3.2Philips Medical Systems, Inc.K896615CINE CAMERA CONTROL MODEL PK2037Perkins Mfg. Co.K881688DTV-4114 FLUOROSCOPIC TELEVISION CAMERAAdac LaboratoriesK853983CANON X-RAY 35MM CINE CAMERA CSI-35Canon 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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