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FDA 510(k)

7200 MA ECHO-OPHTHALMOSCOPE

K-Number: K800100 · 1980-02-21

ApplicantKt Medical, Inc.
Decision Date1980-02-21
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

7200 MA ECHO-OPHTHALMOSCOPE 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 1980-02-21 under 510(k) number K800100. 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 7200 MA ECHO-OPHTHALMOSCOPE?

7200 MA ECHO-OPHTHALMOSCOPE is a medical device that received FDA 510(k) clearance on 1980-02-21. The listed applicant is Kt Medical, Inc.. The 510(k) number is K800100.

When did 7200 MA ECHO-OPHTHALMOSCOPE receive FDA 510(k) clearance?

7200 MA ECHO-OPHTHALMOSCOPE received FDA 510(k) clearance on 1980-02-21, under 510(k) number K800100.

Who is the listed applicant for 7200 MA ECHO-OPHTHALMOSCOPE?

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 7200 MA ECHO-OPHTHALMOSCOPE?

The FDA product code for 7200 MA ECHO-OPHTHALMOSCOPE 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 TIMEK800652MODEL E03 ECHO-OPTHALMOSCOPEK8001014200 ME ECHOENCEPHALOGRAPHK800092COMBISON COMPUTERK800099INTRACULA IIK800093TRANSDUCER

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Related Devices (Code: IYO)

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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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