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FDA 510(k)

PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM

K-Number: K040773 · 2004-04-09

ApplicantBionix Development Corp.
Decision Date2004-04-09
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bionix Development Corp.. It received FDA 510(k) clearance on 2004-04-09 under 510(k) number K040773. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM?

PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM is a medical device that received FDA 510(k) clearance on 2004-04-09. The listed applicant is Bionix Development Corp.. The 510(k) number is K040773.

When did PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM receive FDA 510(k) clearance?

PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM received FDA 510(k) clearance on 2004-04-09, under 510(k) number K040773.

Who is the listed applicant for PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM?

The FDA 510(k) record lists Bionix Development Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM?

The FDA product code for PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM is IYE.

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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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