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FDA 510(k)

MOLDTEC STIMULATOR

K-Number: K853757 · 1986-02-28

ApplicantMoldtec, Inc.
Decision Date1986-02-28
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MOLDTEC STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Moldtec, Inc.. It received FDA 510(k) clearance on 1986-02-28 under 510(k) number K853757. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOLDTEC STIMULATOR?

MOLDTEC STIMULATOR is a medical device that received FDA 510(k) clearance on 1986-02-28. The listed applicant is Moldtec, Inc.. The 510(k) number is K853757.

When did MOLDTEC STIMULATOR receive FDA 510(k) clearance?

MOLDTEC STIMULATOR received FDA 510(k) clearance on 1986-02-28, under 510(k) number K853757.

Who is the listed applicant for MOLDTEC STIMULATOR?

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

What is the FDA product code for MOLDTEC STIMULATOR?

The FDA product code for MOLDTEC STIMULATOR is DRT.

Related Clinical Trials

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Related Devices (Code: DRT)

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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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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