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)

N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028

K-Number: K072067 · 2008-01-08

ApplicantShuenn Bao Shing Corporation
Decision Date2008-01-08
Product CodeMSH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028 is the device name listed in this FDA 510(k) record. The listed applicant is Shuenn Bao Shing Corporation. It received FDA 510(k) clearance on 2008-01-08 under 510(k) number K072067. The device is classified under product code MSH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028?

N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028 is a medical device that received FDA 510(k) clearance on 2008-01-08. The listed applicant is Shuenn Bao Shing Corporation. The 510(k) number is K072067.

When did N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028 receive FDA 510(k) clearance?

N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028 received FDA 510(k) clearance on 2008-01-08, under 510(k) number K072067.

Who is the listed applicant for N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028?

The FDA 510(k) record lists Shuenn Bao Shing Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028?

The FDA product code for N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028 is MSH.

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

Related Devices (Code: MSH)

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.

K233022Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and SmallOwens & Minor (O&M) Halyard, Inc.K172963Master-Frank N95 Particulate RespiratorMaster & Frank Enterprise Co., Ltd.K1711163M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S3M HealthcareK160271N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12San-M Package Co., Ltd.K1210693M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK3M CompanyK102923BARRIER N95 PARTICULATE RESPIRATORMolnlycke Health Care

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.

↑