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FDA 510(k)

ENGSTROM ERICA

K-Number: K812642 · 1981-11-05

ApplicantLkb Instruments, Inc.
Decision Date1981-11-05
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ENGSTROM ERICA is the device name listed in this FDA 510(k) record. The listed applicant is Lkb Instruments, Inc.. It received FDA 510(k) clearance on 1981-11-05 under 510(k) number K812642. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENGSTROM ERICA?

ENGSTROM ERICA is a medical device that received FDA 510(k) clearance on 1981-11-05. The listed applicant is Lkb Instruments, Inc.. The 510(k) number is K812642.

When did ENGSTROM ERICA receive FDA 510(k) clearance?

ENGSTROM ERICA received FDA 510(k) clearance on 1981-11-05, under 510(k) number K812642.

Who is the listed applicant for ENGSTROM ERICA?

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

What is the FDA product code for ENGSTROM ERICA?

The FDA product code for ENGSTROM ERICA is CBK.

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Related Devices (Code: CBK)

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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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