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FDA 510(k)

REDSENSE-ALARM UNIT AND SENSOR

K-Number: K103242 · 2011-02-10

ApplicantRedsense Medical AB
Decision Date2011-02-10
Product CodeODX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

REDSENSE-ALARM UNIT AND SENSOR 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 2011-02-10 under 510(k) number K103242. 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-ALARM UNIT AND SENSOR?

REDSENSE-ALARM UNIT AND SENSOR is a medical device that received FDA 510(k) clearance on 2011-02-10. The listed applicant is Redsense Medical AB. The 510(k) number is K103242.

When did REDSENSE-ALARM UNIT AND SENSOR receive FDA 510(k) clearance?

REDSENSE-ALARM UNIT AND SENSOR received FDA 510(k) clearance on 2011-02-10, under 510(k) number K103242.

Who is the listed applicant for REDSENSE-ALARM UNIT AND SENSOR?

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-ALARM UNIT AND SENSOR?

The FDA product code for REDSENSE-ALARM UNIT AND SENSOR 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 SYSTEMK092955REDSENSE-HOME USEK071013REDSENSE

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 ABK092955REDSENSE-HOME USERedsense 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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