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FDA 510(k)

MODIFICATION TO SYSTEM 83 PLUS

K-Number: K983017 · 1998-09-22

ApplicantCustom Ultrasonics
Decision Date1998-09-22
Product CodeNVE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SYSTEM 83 PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Custom Ultrasonics. It received FDA 510(k) clearance on 1998-09-22 under 510(k) number K983017. The device is classified under product code NVE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO SYSTEM 83 PLUS?

MODIFICATION TO SYSTEM 83 PLUS is a medical device that received FDA 510(k) clearance on 1998-09-22. The listed applicant is Custom Ultrasonics. The 510(k) number is K983017.

When did MODIFICATION TO SYSTEM 83 PLUS receive FDA 510(k) clearance?

MODIFICATION TO SYSTEM 83 PLUS received FDA 510(k) clearance on 1998-09-22, under 510(k) number K983017.

Who is the listed applicant for MODIFICATION TO SYSTEM 83 PLUS?

The FDA 510(k) record lists Custom Ultrasonics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO SYSTEM 83 PLUS?

The FDA product code for MODIFICATION TO SYSTEM 83 PLUS is NVE.

Related Clinical Trials

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.

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Other records listing Custom Ultrasonics 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.

K122172SYSTEM 83 PLUSK061430SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTORK842754CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2

Related Devices (Code: NVE)

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.

K222849AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer DisinfectorSterisK222543AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer DisinfectorSterisK203199RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-DisinfectorSTERIS CorporationK200577RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/DisinfectorSTERIS CorporationK190081RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/DisinfectorSTERIS CorporationK073112DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253Intuitive Surgical, 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.

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