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FDA 510(k)

BACK-ON-TRAC, MODEL 101BOT

K-Number: K984190 · 1999-03-15

ApplicantBack-On-Track, Inc.
Decision Date1999-03-15
Product CodeHST
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BACK-ON-TRAC, MODEL 101BOT is the device name listed in this FDA 510(k) record. The listed applicant is Back-On-Track, Inc.. It received FDA 510(k) clearance on 1999-03-15 under 510(k) number K984190. The device is classified under product code HST. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BACK-ON-TRAC, MODEL 101BOT?

BACK-ON-TRAC, MODEL 101BOT is a medical device that received FDA 510(k) clearance on 1999-03-15. The listed applicant is Back-On-Track, Inc.. The 510(k) number is K984190.

When did BACK-ON-TRAC, MODEL 101BOT receive FDA 510(k) clearance?

BACK-ON-TRAC, MODEL 101BOT received FDA 510(k) clearance on 1999-03-15, under 510(k) number K984190.

Who is the listed applicant for BACK-ON-TRAC, MODEL 101BOT?

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

What is the FDA product code for BACK-ON-TRAC, MODEL 101BOT?

The FDA product code for BACK-ON-TRAC, MODEL 101BOT is HST.

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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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