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FDA 510(k)

VARI-ABLE APB (ADAPTABLE POSITIONING BASE)

K-Number: K042401 · 2004-10-07

ApplicantAmerican Track Roadsters, Inc.
Decision Date2004-10-07
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

VARI-ABLE APB (ADAPTABLE POSITIONING BASE) is the device name listed in this FDA 510(k) record. The listed applicant is American Track Roadsters, Inc.. It received FDA 510(k) clearance on 2004-10-07 under 510(k) number K042401. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARI-ABLE APB (ADAPTABLE POSITIONING BASE)?

VARI-ABLE APB (ADAPTABLE POSITIONING BASE) is a medical device that received FDA 510(k) clearance on 2004-10-07. The listed applicant is American Track Roadsters, Inc.. The 510(k) number is K042401.

When did VARI-ABLE APB (ADAPTABLE POSITIONING BASE) receive FDA 510(k) clearance?

VARI-ABLE APB (ADAPTABLE POSITIONING BASE) received FDA 510(k) clearance on 2004-10-07, under 510(k) number K042401.

Who is the listed applicant for VARI-ABLE APB (ADAPTABLE POSITIONING BASE)?

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

What is the FDA product code for VARI-ABLE APB (ADAPTABLE POSITIONING BASE)?

The FDA product code for VARI-ABLE APB (ADAPTABLE POSITIONING BASE) is IOR.

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Related Devices (Code: IOR)

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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