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FDA 510(k)

MODEL E03 ECHO-OPTHALMOSCOPE

K-Number: K800652 · 1980-05-14

ApplicantKt Medical, Inc.
Decision Date1980-05-14
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODEL E03 ECHO-OPTHALMOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Kt Medical, Inc.. It received FDA 510(k) clearance on 1980-05-14 under 510(k) number K800652. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL E03 ECHO-OPTHALMOSCOPE?

MODEL E03 ECHO-OPTHALMOSCOPE is a medical device that received FDA 510(k) clearance on 1980-05-14. The listed applicant is Kt Medical, Inc.. The 510(k) number is K800652.

When did MODEL E03 ECHO-OPTHALMOSCOPE receive FDA 510(k) clearance?

MODEL E03 ECHO-OPTHALMOSCOPE received FDA 510(k) clearance on 1980-05-14, under 510(k) number K800652.

Who is the listed applicant for MODEL E03 ECHO-OPTHALMOSCOPE?

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

What is the FDA product code for MODEL E03 ECHO-OPTHALMOSCOPE?

The FDA product code for MODEL E03 ECHO-OPTHALMOSCOPE is IYO.

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Other records listing Kt Medical, 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.

K800653SINVISION LINEAR ARRAY REAL TIMEK8001014200 ME ECHOENCEPHALOGRAPHK800092COMBISON COMPUTERK800099INTRACULA IIK8001007200 MA ECHO-OPHTHALMOSCOPEK800093TRANSDUCER

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Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, 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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