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)

NITELIFE BI-LEVEL CPAP

K-Number: K943207 · 1996-07-29

ApplicantAirsep Corp.
Decision Date1996-07-29
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NITELIFE BI-LEVEL CPAP is the device name listed in this FDA 510(k) record. The listed applicant is Airsep Corp.. It received FDA 510(k) clearance on 1996-07-29 under 510(k) number K943207. 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 NITELIFE BI-LEVEL CPAP?

NITELIFE BI-LEVEL CPAP is a medical device that received FDA 510(k) clearance on 1996-07-29. The listed applicant is Airsep Corp.. The 510(k) number is K943207.

When did NITELIFE BI-LEVEL CPAP receive FDA 510(k) clearance?

NITELIFE BI-LEVEL CPAP received FDA 510(k) clearance on 1996-07-29, under 510(k) number K943207.

Who is the listed applicant for NITELIFE BI-LEVEL CPAP?

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

What is the FDA product code for NITELIFE BI-LEVEL CPAP?

The FDA product code for NITELIFE BI-LEVEL CPAP 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 Airsep Corp. 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.

K101154CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-LK080348OXISCAN II DATA MANAGEMENT SYSTEMK020324LIFESTYLE OXYGEN CONCENTRATORK012037HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009K000963DA VINCHI EEG AND EMG/EP SYSTEMSK001579IMPULSE SELECT

View all 18 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.

↑