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FDA 510(k)

IBED WIRELESS WITH IBED AWARENESS

K-Number: K103536 · 2010-12-16

ApplicantStryker Corporation
Decision Date2010-12-16
Product CodeFNL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IBED WIRELESS WITH IBED AWARENESS is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2010-12-16 under 510(k) number K103536. The device is classified under product code FNL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IBED WIRELESS WITH IBED AWARENESS?

IBED WIRELESS WITH IBED AWARENESS is a medical device that received FDA 510(k) clearance on 2010-12-16. The listed applicant is Stryker Corporation. The 510(k) number is K103536.

When did IBED WIRELESS WITH IBED AWARENESS receive FDA 510(k) clearance?

IBED WIRELESS WITH IBED AWARENESS received FDA 510(k) clearance on 2010-12-16, under 510(k) number K103536.

Who is the listed applicant for IBED WIRELESS WITH IBED AWARENESS?

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

What is the FDA product code for IBED WIRELESS WITH IBED AWARENESS?

The FDA product code for IBED WIRELESS WITH IBED AWARENESS is FNL.

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Related Devices (Code: FNL)

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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