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FDA 510(k)

SONEL 3000A

K-Number: K833223 · 1984-05-09

ApplicantCgr Medical Corp.
Decision Date1984-05-09
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONEL 3000A is the device name listed in this FDA 510(k) record. The listed applicant is Cgr Medical Corp.. It received FDA 510(k) clearance on 1984-05-09 under 510(k) number K833223. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONEL 3000A?

SONEL 3000A is a medical device that received FDA 510(k) clearance on 1984-05-09. The listed applicant is Cgr Medical Corp.. The 510(k) number is K833223.

When did SONEL 3000A receive FDA 510(k) clearance?

SONEL 3000A received FDA 510(k) clearance on 1984-05-09, under 510(k) number K833223.

Who is the listed applicant for SONEL 3000A?

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

What is the FDA product code for SONEL 3000A?

The FDA product code for SONEL 3000A is IYO.

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Other records listing Cgr Medical Corp. 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.

K843926PRESTILIX 1690K843235STENOSCOPK843985SUSPENSION 7K841649MAXIMAX - 4K833941ORIONK834306PHASIX-HIGH FREQUENCY GENERATOR

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Related Devices (Code: IYO)

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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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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