Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SOMNOMED BFLEX

K-Number: K073004 · 2008-01-30

ApplicantSomnomed, Inc.
Decision Date2008-01-30
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOMNOMED BFLEX is the device name listed in this FDA 510(k) record. The listed applicant is Somnomed, Inc.. It received FDA 510(k) clearance on 2008-01-30 under 510(k) number K073004. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOMNOMED BFLEX?

SOMNOMED BFLEX is a medical device that received FDA 510(k) clearance on 2008-01-30. The listed applicant is Somnomed, Inc.. The 510(k) number is K073004.

When did SOMNOMED BFLEX receive FDA 510(k) clearance?

SOMNOMED BFLEX received FDA 510(k) clearance on 2008-01-30, under 510(k) number K073004.

Who is the listed applicant for SOMNOMED BFLEX?

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

What is the FDA product code for SOMNOMED BFLEX?

The FDA product code for SOMNOMED BFLEX is LRK.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Somnomed, Inc. 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.

K261366VirtusK233497Rest Assure SystemK183443SomnoDent AvantK162306SomnoDent ALPHAK130558SOMNODENT HERBST; CLASSIC, FLEXK121340SOMNODENT G2

View all 9 devices →

Related Devices (Code: LRK)

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.

K262104Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)Ram.Shaw Pte., Ltd.K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLC

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.

↑