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FDA 510(k)

LC, CARDIAC POSITIONER #B5078A

K-Number: K890348 · 1989-02-27

ApplicantGeneral Electric Co.
Decision Date1989-02-27
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LC, CARDIAC POSITIONER #B5078A is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 1989-02-27 under 510(k) number K890348. 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 LC, CARDIAC POSITIONER #B5078A?

LC, CARDIAC POSITIONER #B5078A is a medical device that received FDA 510(k) clearance on 1989-02-27. The listed applicant is General Electric Co.. The 510(k) number is K890348.

When did LC, CARDIAC POSITIONER #B5078A receive FDA 510(k) clearance?

LC, CARDIAC POSITIONER #B5078A received FDA 510(k) clearance on 1989-02-27, under 510(k) number K890348.

Who is the listed applicant for LC, CARDIAC POSITIONER #B5078A?

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

What is the FDA product code for LC, CARDIAC POSITIONER #B5078A?

The FDA product code for LC, CARDIAC POSITIONER #B5078A is IZI.

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Other records listing General Electric Co. as applicant

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Related Devices (Code: IZI)

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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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