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)

RESPIRE PINK SERIES - HERBST

K-Number: K131138 · 2013-09-09

ApplicantRespire Medical
Decision Date2013-09-09
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RESPIRE PINK SERIES - HERBST is the device name listed in this FDA 510(k) record. The listed applicant is Respire Medical. It received FDA 510(k) clearance on 2013-09-09 under 510(k) number K131138. 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 RESPIRE PINK SERIES - HERBST?

RESPIRE PINK SERIES - HERBST is a medical device that received FDA 510(k) clearance on 2013-09-09. The listed applicant is Respire Medical. The 510(k) number is K131138.

When did RESPIRE PINK SERIES - HERBST receive FDA 510(k) clearance?

RESPIRE PINK SERIES - HERBST received FDA 510(k) clearance on 2013-09-09, under 510(k) number K131138.

Who is the listed applicant for RESPIRE PINK SERIES - HERBST?

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

What is the FDA product code for RESPIRE PINK SERIES - HERBST?

The FDA product code for RESPIRE PINK SERIES - HERBST 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 Respire Medical 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.

K111207RESPIRE BLUE SERIES

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.

↑