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FDA 510(k)

CRM-114 COLOR VIDEO CAMERA

K-Number: K830924 · 1983-04-18

ApplicantUmi, Inc.
Decision Date1983-04-18
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CRM-114 COLOR VIDEO CAMERA is the device name listed in this FDA 510(k) record. The listed applicant is Umi, Inc.. It received FDA 510(k) clearance on 1983-04-18 under 510(k) number K830924. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRM-114 COLOR VIDEO CAMERA?

CRM-114 COLOR VIDEO CAMERA is a medical device that received FDA 510(k) clearance on 1983-04-18. The listed applicant is Umi, Inc.. The 510(k) number is K830924.

When did CRM-114 COLOR VIDEO CAMERA receive FDA 510(k) clearance?

CRM-114 COLOR VIDEO CAMERA received FDA 510(k) clearance on 1983-04-18, under 510(k) number K830924.

Who is the listed applicant for CRM-114 COLOR VIDEO CAMERA?

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

What is the FDA product code for CRM-114 COLOR VIDEO CAMERA?

The FDA product code for CRM-114 COLOR VIDEO CAMERA is FET.

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.

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Other records listing Umi, 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.

K883527GRID/RADIOGRAPHICK831412CRM-100 COLOR VIDEO CAMERAK823382NEPHROSTOMY CATHETER

Related Devices (Code: FET)

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.

K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp.K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm CorporationK261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems CorporationK251734ProVee Video Processing Unit (PV-003)Proverum LimitedK250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private LimitedK250204Endoscopic Camera SystemShenzhen Sophway Technology Co., Ltd.

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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