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FDA 510(k)

SONY CINE VIDEO SYSTEM SME-3500

K-Number: K904447 · 1990-10-17

ApplicantSony Medical Electronics Co.
Decision Date1990-10-17
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONY CINE VIDEO SYSTEM SME-3500 is the device name listed in this FDA 510(k) record. The listed applicant is Sony Medical Electronics Co.. It received FDA 510(k) clearance on 1990-10-17 under 510(k) number K904447. 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 SONY CINE VIDEO SYSTEM SME-3500?

SONY CINE VIDEO SYSTEM SME-3500 is a medical device that received FDA 510(k) clearance on 1990-10-17. The listed applicant is Sony Medical Electronics Co.. The 510(k) number is K904447.

When did SONY CINE VIDEO SYSTEM SME-3500 receive FDA 510(k) clearance?

SONY CINE VIDEO SYSTEM SME-3500 received FDA 510(k) clearance on 1990-10-17, under 510(k) number K904447.

Who is the listed applicant for SONY CINE VIDEO SYSTEM SME-3500?

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

What is the FDA product code for SONY CINE VIDEO SYSTEM SME-3500?

The FDA product code for SONY CINE VIDEO SYSTEM SME-3500 is IZI.

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Other records listing Sony Medical Electronics Co. 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.

K980279SONY DXC-LS1 COLOR VIDEO CAMERAK913886SONY DVR-10 DIGITAL VIDEOCASSETTE RECORDERK902535SONY WBS-700H VIDEOCASSETTE RECORDER SYSTEMK901153SONY VO-5800H VIDEOCASSETTE RECORDERK885042SONY TRINITRON COLOR VIDEO MONITOR PVM-1343MDK884008SONY CINE VIDEO SYSTEM SME-3300

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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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