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FDA 510(k)

REDSENSE

K-Number: K071013 · 2007-10-18

ApplicantRedsense Medical AB
Decision Date2007-10-18
Product CodeODX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

REDSENSE 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 2007-10-18 under 510(k) number K071013. 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?

REDSENSE is a medical device that received FDA 510(k) clearance on 2007-10-18. The listed applicant is Redsense Medical AB. The 510(k) number is K071013.

When did REDSENSE receive FDA 510(k) clearance?

REDSENSE received FDA 510(k) clearance on 2007-10-18, under 510(k) number K071013.

Who is the listed applicant for REDSENSE?

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?

The FDA product code for REDSENSE is ODX.

Related Clinical Trials

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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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 SENSORK092955REDSENSE-HOME USE

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 ABK092955REDSENSE-HOME USERedsense Medical AB

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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