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FDA 510(k)

PRONE BREAST POSITIONING BOARD, MODEL #37-018

K-Number: K971382 · 1997-06-06

ApplicantVictoreen, Inc.
Decision Date1997-06-06
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PRONE BREAST POSITIONING BOARD, MODEL #37-018 is the device name listed in this FDA 510(k) record. The listed applicant is Victoreen, Inc.. It received FDA 510(k) clearance on 1997-06-06 under 510(k) number K971382. 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 PRONE BREAST POSITIONING BOARD, MODEL #37-018?

PRONE BREAST POSITIONING BOARD, MODEL #37-018 is a medical device that received FDA 510(k) clearance on 1997-06-06. The listed applicant is Victoreen, Inc.. The 510(k) number is K971382.

When did PRONE BREAST POSITIONING BOARD, MODEL #37-018 receive FDA 510(k) clearance?

PRONE BREAST POSITIONING BOARD, MODEL #37-018 received FDA 510(k) clearance on 1997-06-06, under 510(k) number K971382.

Who is the listed applicant for PRONE BREAST POSITIONING BOARD, MODEL #37-018?

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

What is the FDA product code for PRONE BREAST POSITIONING BOARD, MODEL #37-018?

The FDA product code for PRONE BREAST POSITIONING BOARD, MODEL #37-018 is IYE.

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Other records listing Victoreen, Inc. as applicant

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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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