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FDA 510(k)

HANS RUDOLPH NASAL CPAP MASK

K-Number: K962848 · 1996-10-16

ApplicantHans Rudolph, Inc.
Decision Date1996-10-16
Product CodeBYG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HANS RUDOLPH NASAL CPAP MASK 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 1996-10-16 under 510(k) number K962848. The device is classified under product code BYG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HANS RUDOLPH NASAL CPAP MASK?

HANS RUDOLPH NASAL CPAP MASK is a medical device that received FDA 510(k) clearance on 1996-10-16. The listed applicant is Hans Rudolph, Inc.. The 510(k) number is K962848.

When did HANS RUDOLPH NASAL CPAP MASK receive FDA 510(k) clearance?

HANS RUDOLPH NASAL CPAP MASK received FDA 510(k) clearance on 1996-10-16, under 510(k) number K962848.

Who is the listed applicant for HANS RUDOLPH NASAL CPAP MASK?

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 HANS RUDOLPH NASAL CPAP MASK?

The FDA product code for HANS RUDOLPH NASAL CPAP MASK is BYG.

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.

K071149HRI 6500, 6600 AND 6700 SERIES V2MASKSK0308227600 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 PETITK960401ULTIMATE SEALK946077DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS

View all 11 devices →

Related Devices (Code: BYG)

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.

K963298FIRST AID KIT(S)Vector, Inc.K945482DISPOSABLE, CPAP OXYGEN MASKFvtnksK953464WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASKWestmed, Inc.K953039VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKSDadsun Corp., Ltd.K945472WESTMED PEDIATRIC AND ADULT AEROSOL MASKWestmed Intl.K942907JEMSDAL MASKRespan Products, Inc.

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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