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FDA 510(k)

MIS

K-Number: K923543 · 1993-03-29

ApplicantCeram Optec, Inc.
Decision Date1993-03-29
Product CodeHLJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MIS is the device name listed in this FDA 510(k) record. The listed applicant is Ceram Optec, Inc.. It received FDA 510(k) clearance on 1993-03-29 under 510(k) number K923543. The device is classified under product code HLJ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIS?

MIS is a medical device that received FDA 510(k) clearance on 1993-03-29. The listed applicant is Ceram Optec, Inc.. The 510(k) number is K923543.

When did MIS receive FDA 510(k) clearance?

MIS received FDA 510(k) clearance on 1993-03-29, under 510(k) number K923543.

Who is the listed applicant for MIS?

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

What is the FDA product code for MIS?

The FDA product code for MIS is HLJ.

Related PubMed Literature

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Other records listing Ceram Optec, 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.

K002296CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15K001975CERALAS D10 810NM LASER, MODEL CERALAS D10-60K993911CERALAS D DIODE LASER SYSTEM, MODEL D15, D25,D50K993828CERALAS D10 810NM DIODE LASERK993002CERALAS D 980NM DIODE LASER SYSTEM, MODEL D15K992773CERALAS D10 810NM DIODE LASER

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Related Devices (Code: HLJ)

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.

K131961HEINE BETA 200(R) OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGK131719OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITSMedical Devices (Pvt) , Ltd.K123587HEINE MINI 3000 LED OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGK093495OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITSAmerican Diagnostic Corp.K070270PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36Kirchner & Wilhelm GmbH + Co.KgK05259966 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25ASuzhou 66 Vision Tech 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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