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FDA 510(k)

CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V)

K-Number: K921465 · 1992-06-29

ApplicantHelena Laboratories
Decision Date1992-06-29
Product CodeGKP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V) is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1992-06-29 under 510(k) number K921465. The device is classified under product code GKP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V)?

CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V) is a medical device that received FDA 510(k) clearance on 1992-06-29. The listed applicant is Helena Laboratories. The 510(k) number is K921465.

When did CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V) receive FDA 510(k) clearance?

CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V) received FDA 510(k) clearance on 1992-06-29, under 510(k) number K921465.

Who is the listed applicant for CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V)?

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

What is the FDA product code for CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V)?

The FDA product code for CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V) is GKP.

Other records listing Helena Laboratories as applicant

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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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