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FDA 510(k)

ULTRASCAN DIGITAL A/SYSTEM III

K-Number: K828328 · 1983-03-03

ApplicantCooper Lasersonics, Inc.
Decision Date1983-03-03
Product Code
DecisionSubstantially Equivalent

Device Summary

ULTRASCAN DIGITAL A/SYSTEM III is the device name listed in this FDA 510(k) record. The listed applicant is Cooper Lasersonics, Inc.. It received FDA 510(k) clearance on 1983-03-03 under 510(k) number K828328. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASCAN DIGITAL A/SYSTEM III?

ULTRASCAN DIGITAL A/SYSTEM III is a medical device that received FDA 510(k) clearance on 1983-03-03. The listed applicant is Cooper Lasersonics, Inc.. The 510(k) number is K828328.

When did ULTRASCAN DIGITAL A/SYSTEM III receive FDA 510(k) clearance?

ULTRASCAN DIGITAL A/SYSTEM III received FDA 510(k) clearance on 1983-03-03, under 510(k) number K828328.

Who is the listed applicant for ULTRASCAN DIGITAL A/SYSTEM III?

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

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Other records listing Cooper Lasersonics, 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.

K880427ILLUMINA 40 CO2 LASER SYSTEMK880808ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SUK880429ILLUMINA 55 CO2 LASER SYSTEMK880428ILLUMINA 25 CO2 LASER SYSTEMK880807ILLUMINA MODEL 25 CO2 LASER FOR GENERAL/PLASTIC SUK880809ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SU

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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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