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FDA 510(k)

STOLTRONICS-LRS

K-Number: K813637 · 1982-02-04

ApplicantStoltronic Systems, Inc.
Decision Date1982-02-04
Product CodeKCW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STOLTRONICS-LRS is the device name listed in this FDA 510(k) record. The listed applicant is Stoltronic Systems, Inc.. It received FDA 510(k) clearance on 1982-02-04 under 510(k) number K813637. The device is classified under product code KCW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STOLTRONICS-LRS?

STOLTRONICS-LRS is a medical device that received FDA 510(k) clearance on 1982-02-04. The listed applicant is Stoltronic Systems, Inc.. The 510(k) number is K813637.

When did STOLTRONICS-LRS receive FDA 510(k) clearance?

STOLTRONICS-LRS received FDA 510(k) clearance on 1982-02-04, under 510(k) number K813637.

Who is the listed applicant for STOLTRONICS-LRS?

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

What is the FDA product code for STOLTRONICS-LRS?

The FDA product code for STOLTRONICS-LRS is KCW.

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Related Devices (Code: KCW)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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