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FDA 510(k)

REDSENSE-HOME USE

K-Number: K092955 · 2010-05-10

ApplicantRedsense Medical AB
Decision Date2010-05-10
Product CodeODX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

REDSENSE-HOME USE is the device name listed in this FDA 510(k) record. The listed applicant is Redsense Medical AB. It received FDA 510(k) clearance on 2010-05-10 under 510(k) number K092955. The device is classified under product code ODX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REDSENSE-HOME USE?

REDSENSE-HOME USE is a medical device that received FDA 510(k) clearance on 2010-05-10. The listed applicant is Redsense Medical AB. The 510(k) number is K092955.

When did REDSENSE-HOME USE receive FDA 510(k) clearance?

REDSENSE-HOME USE received FDA 510(k) clearance on 2010-05-10, under 510(k) number K092955.

Who is the listed applicant for REDSENSE-HOME USE?

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

What is the FDA product code for REDSENSE-HOME USE?

The FDA product code for REDSENSE-HOME USE is ODX.

Related Clinical Trials

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Other records listing Redsense Medical AB as applicant

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.

K130554REDSENSE ALARM SYSTEMK103242REDSENSE-ALARM UNIT AND SENSORK071013REDSENSE

Related Devices (Code: ODX)

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.

K130554REDSENSE ALARM SYSTEMRedsense Medical ABK103242REDSENSE-ALARM UNIT AND SENSORRedsense Medical ABK071013REDSENSERedsense Medical AB

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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