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FDA 510(k)

DORNIR LC-1 CPAP SYSTEM

K-Number: K010704 · 2001-04-18

ApplicantPrym Medical , Ltd.
Decision Date2001-04-18
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DORNIR LC-1 CPAP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Prym Medical , Ltd.. It received FDA 510(k) clearance on 2001-04-18 under 510(k) number K010704. 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 DORNIR LC-1 CPAP SYSTEM?

DORNIR LC-1 CPAP SYSTEM is a medical device that received FDA 510(k) clearance on 2001-04-18. The listed applicant is Prym Medical , Ltd.. The 510(k) number is K010704.

When did DORNIR LC-1 CPAP SYSTEM receive FDA 510(k) clearance?

DORNIR LC-1 CPAP SYSTEM received FDA 510(k) clearance on 2001-04-18, under 510(k) number K010704.

Who is the listed applicant for DORNIR LC-1 CPAP SYSTEM?

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

What is the FDA product code for DORNIR LC-1 CPAP SYSTEM?

The FDA product code for DORNIR LC-1 CPAP SYSTEM 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 Prym Medical , Ltd. 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.

K000888SANSIBAR CPAP SYSTEM

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.

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