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FDA 510(k)

SIDE RAIL PADS

K-Number: K823821 · 1983-01-21

ApplicantDanek Medical, Inc.
Decision Date1983-01-21
Product CodeFNJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SIDE RAIL PADS is the device name listed in this FDA 510(k) record. The listed applicant is Danek Medical, Inc.. It received FDA 510(k) clearance on 1983-01-21 under 510(k) number K823821. The device is classified under product code FNJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIDE RAIL PADS?

SIDE RAIL PADS is a medical device that received FDA 510(k) clearance on 1983-01-21. The listed applicant is Danek Medical, Inc.. The 510(k) number is K823821.

When did SIDE RAIL PADS receive FDA 510(k) clearance?

SIDE RAIL PADS received FDA 510(k) clearance on 1983-01-21, under 510(k) number K823821.

Who is the listed applicant for SIDE RAIL PADS?

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

What is the FDA product code for SIDE RAIL PADS?

The FDA product code for SIDE RAIL PADS is FNJ.

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Related Devices (Code: FNJ)

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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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