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)

HRI 6500, 6600 AND 6700 SERIES V2MASKS

K-Number: K071149 · 2008-02-01

ApplicantHans Rudolph, Inc.
Decision Date2008-02-01
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HRI 6500, 6600 AND 6700 SERIES V2MASKS is the device name listed in this FDA 510(k) record. The listed applicant is Hans Rudolph, Inc.. It received FDA 510(k) clearance on 2008-02-01 under 510(k) number K071149. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HRI 6500, 6600 AND 6700 SERIES V2MASKS?

HRI 6500, 6600 AND 6700 SERIES V2MASKS is a medical device that received FDA 510(k) clearance on 2008-02-01. The listed applicant is Hans Rudolph, Inc.. The 510(k) number is K071149.

When did HRI 6500, 6600 AND 6700 SERIES V2MASKS receive FDA 510(k) clearance?

HRI 6500, 6600 AND 6700 SERIES V2MASKS received FDA 510(k) clearance on 2008-02-01, under 510(k) number K071149.

Who is the listed applicant for HRI 6500, 6600 AND 6700 SERIES V2MASKS?

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

What is the FDA product code for HRI 6500, 6600 AND 6700 SERIES V2MASKS?

The FDA product code for HRI 6500, 6600 AND 6700 SERIES V2MASKS is BZD.

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 Hans Rudolph, 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.

K0308227600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKSK030515HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKSK0207597600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETITK962848HANS RUDOLPH NASAL CPAP MASKK960401ULTIMATE SEALK946077DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS

View all 11 devices →

Related Devices (Code: BZD)

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.

K261262Altis Full Face MaskRespironics, Inc.K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.

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.

↑