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FDA 510(k)

MINIVISOR

K-Number: K780035 · 1978-03-06

ApplicantMetrix Teknika, Inc.
Decision Date1978-03-06
Product CodeHEL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MINIVISOR is the device name listed in this FDA 510(k) record. The listed applicant is Metrix Teknika, Inc.. It received FDA 510(k) clearance on 1978-03-06 under 510(k) number K780035. The device is classified under product code HEL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINIVISOR?

MINIVISOR is a medical device that received FDA 510(k) clearance on 1978-03-06. The listed applicant is Metrix Teknika, Inc.. The 510(k) number is K780035.

When did MINIVISOR receive FDA 510(k) clearance?

MINIVISOR received FDA 510(k) clearance on 1978-03-06, under 510(k) number K780035.

Who is the listed applicant for MINIVISOR?

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

What is the FDA product code for MINIVISOR?

The FDA product code for MINIVISOR is HEL.

Related Clinical Trials

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Other records listing Metrix Teknika, 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.

K781803FILTER, EYRPUR DISPOSABLE LEUKOCITEK781802WASHER SYSTEM, MICROELISAK781348FOCISCAN ECHOVISOR SYSTEM

Related Devices (Code: HEL)

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.

K003876US SENSOR #CG-930P; TOCO SENSOR CG-940PCard Guard Scientific Survival , Ltd.K010920TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORINGMedical Cables, Inc.K982651COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCERCorometrics Medical Systems, Inc.K971240ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006Alexander Mfg. Co.K930714SONICAID MODEL TEAM FECG IUPOxford Instruments, Plc.K933816SONICAID MODEL P110 FETAL HEAR DETECTOROxford Instruments, Plc.

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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