FDA 510(k)

ACCU-STAR

K-Number: K922446 · 1992-08-05

Decision Date1992-08-05

Product CodeEJS

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ACCU-STAR is the device name listed in this FDA 510(k) record. The listed applicant is J.F. Jelenko & Co., Inc.. It received FDA 510(k) clearance on 1992-08-05 under 510(k) number K922446. The device is classified under product code EJS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCU-STAR?

ACCU-STAR is a medical device that received FDA 510(k) clearance on 1992-08-05. The listed applicant is J.F. Jelenko & Co., Inc.. The 510(k) number is K922446.

When did ACCU-STAR receive FDA 510(k) clearance?

ACCU-STAR received FDA 510(k) clearance on 1992-08-05, under 510(k) number K922446.

Who is the listed applicant for ACCU-STAR?

The FDA 510(k) record lists J.F. Jelenko & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCU-STAR?

The FDA product code for ACCU-STAR is EJS.

Other records listing J.F. Jelenko & Co., 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.

K012303JEL-20 K002993HERACERAM K002645JEL BIOS PURE K002222RD-2104 K001360SIGNUM K001260ALLROUND 55 LF

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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.