Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

COMPUTERSCOPE CPS-ABR

K-Number: K833413 · 1983-11-28

Decision Date1983-11-28
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

COMPUTERSCOPE CPS-ABR is the device name listed in this FDA 510(k) record. The listed applicant is Rc Electronics, Inc.. It received FDA 510(k) clearance on 1983-11-28 under 510(k) number K833413. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPUTERSCOPE CPS-ABR?

COMPUTERSCOPE CPS-ABR is a medical device that received FDA 510(k) clearance on 1983-11-28. The listed applicant is Rc Electronics, Inc.. The 510(k) number is K833413.

When did COMPUTERSCOPE CPS-ABR receive FDA 510(k) clearance?

COMPUTERSCOPE CPS-ABR received FDA 510(k) clearance on 1983-11-28, under 510(k) number K833413.

Who is the listed applicant for COMPUTERSCOPE CPS-ABR?

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

What is the FDA product code for COMPUTERSCOPE CPS-ABR?

The FDA product code for COMPUTERSCOPE CPS-ABR is GWL.

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.

Related Devices (Code: GWL)

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.

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.

↑