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FDA 510(k)

VIBROFLEX

K-Number: K863197 · 1986-09-19

ApplicantStoffregen & Co., Inc.
Decision Date1986-09-19
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

VIBROFLEX is the device name listed in this FDA 510(k) record. The listed applicant is Stoffregen & Co., Inc.. It received FDA 510(k) clearance on 1986-09-19 under 510(k) number K863197. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIBROFLEX?

VIBROFLEX is a medical device that received FDA 510(k) clearance on 1986-09-19. The listed applicant is Stoffregen & Co., Inc.. The 510(k) number is K863197.

When did VIBROFLEX receive FDA 510(k) clearance?

VIBROFLEX received FDA 510(k) clearance on 1986-09-19, under 510(k) number K863197.

Who is the listed applicant for VIBROFLEX?

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

What is the FDA product code for VIBROFLEX?

The FDA product code for VIBROFLEX is ISA.

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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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