FDA 510(k)

OPTI-DISC

K-Number: K820626 · 1982-04-09

Decision Date1982-04-09

Product CodeKQM

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

OPTI-DISC is the device name listed in this FDA 510(k) record. The listed applicant is Video-Medical Devices, Ltd.. It received FDA 510(k) clearance on 1982-04-09 under 510(k) number K820626. The device is classified under product code KQM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTI-DISC?

OPTI-DISC is a medical device that received FDA 510(k) clearance on 1982-04-09. The listed applicant is Video-Medical Devices, Ltd.. The 510(k) number is K820626.

When did OPTI-DISC receive FDA 510(k) clearance?

OPTI-DISC received FDA 510(k) clearance on 1982-04-09, under 510(k) number K820626.

Who is the listed applicant for OPTI-DISC?

The FDA 510(k) record lists Video-Medical Devices, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTI-DISC?

The FDA product code for OPTI-DISC is KQM.

Related Devices (Code: KQM)

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.

K900160ADAPTOR: KAPS CINE TO MOELLER BEAMSPLITTERJedmed Instrument Co.K890826SONY VIDEO GRAPHIC PRINTER UP-850Sony Corp. of America K885042SONY TRINITRON COLOR VIDEO MONITOR PVM-1343MDSony Medical Electronics Co.K882958SONY VIDEO PRINTERS, UP SERIESSony Medical Electronics Co.K882924MEDICAM MC-7 AND RP-7 SURGICAL CAMERASM.P. Video, Inc.K873419VIDEO PRINTER SYSTEMTechnology For Imaging, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.