FDA 510(k)

GALTEL-18

K-Number: K821850 · 1982-07-28

ApplicantGalvanic Medical Instruments, Inc.

Decision Date1982-07-28

Product Code

DecisionSubstantially Equivalent

Device Summary

GALTEL-18 is the device name listed in this FDA 510(k) record. The listed applicant is Galvanic Medical Instruments, Inc.. It received FDA 510(k) clearance on 1982-07-28 under 510(k) number K821850. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GALTEL-18?

GALTEL-18 is a medical device that received FDA 510(k) clearance on 1982-07-28. The listed applicant is Galvanic Medical Instruments, Inc.. The 510(k) number is K821850.

When did GALTEL-18 receive FDA 510(k) clearance?

GALTEL-18 received FDA 510(k) clearance on 1982-07-28, under 510(k) number K821850.

Who is the listed applicant for GALTEL-18?

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

Related Clinical Trials

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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Other records listing Galvanic Medical Instruments, Inc. as applicant

K851318GUIBOR MICROELECTROLYSIS UNIT 18

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.