FDA 510(k)

B1 FOOTSWITCH (SINGLE PEDDLE), B2 (DOUBLE PEDDLE)

K-Number: K894602 · 1989-08-09

Decision Date1989-08-09

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

B1 FOOTSWITCH (SINGLE PEDDLE), B2 (DOUBLE PEDDLE) is the device name listed in this FDA 510(k) record. The listed applicant is Beacon Laboratories, Inc.. It received FDA 510(k) clearance on 1989-08-09 under 510(k) number K894602. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B1 FOOTSWITCH (SINGLE PEDDLE), B2 (DOUBLE PEDDLE)?

B1 FOOTSWITCH (SINGLE PEDDLE), B2 (DOUBLE PEDDLE) is a medical device that received FDA 510(k) clearance on 1989-08-09. The listed applicant is Beacon Laboratories, Inc.. The 510(k) number is K894602.

When did B1 FOOTSWITCH (SINGLE PEDDLE), B2 (DOUBLE PEDDLE) receive FDA 510(k) clearance?

B1 FOOTSWITCH (SINGLE PEDDLE), B2 (DOUBLE PEDDLE) received FDA 510(k) clearance on 1989-08-09, under 510(k) number K894602.

Who is the listed applicant for B1 FOOTSWITCH (SINGLE PEDDLE), B2 (DOUBLE PEDDLE)?

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

What is the FDA product code for B1 FOOTSWITCH (SINGLE PEDDLE), B2 (DOUBLE PEDDLE)?

The FDA product code for B1 FOOTSWITCH (SINGLE PEDDLE), B2 (DOUBLE PEDDLE) is GEI.

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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.