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FDA 510(k)

REMBRANDT SYSTEM

K-Number: K962865 · 1996-10-25

ApplicantAirsep Corp.
Decision Date1996-10-25
Product CodeFLS
Advisory CommitteeAN
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

REMBRANDT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Airsep Corp.. It received FDA 510(k) clearance on 1996-10-25 under 510(k) number K962865. The device is classified under product code FLS. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the REMBRANDT SYSTEM?

REMBRANDT SYSTEM is a medical device that received FDA 510(k) clearance on 1996-10-25. The listed applicant is Airsep Corp.. The 510(k) number is K962865.

When did REMBRANDT SYSTEM receive FDA 510(k) clearance?

REMBRANDT SYSTEM received FDA 510(k) clearance on 1996-10-25, under 510(k) number K962865.

Who is the listed applicant for REMBRANDT SYSTEM?

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 REMBRANDT SYSTEM?

The FDA product code for REMBRANDT SYSTEM is FLS.

Related Clinical Trials

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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

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Related Devices (Code: FLS)

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.

K011597SMARTMONITOR 2, MODEL 4000Respironics Georgia, Inc.K991087HANNAH WIRELESS VITAL SIGNS MONITORIlife Systems, Inc.K951246PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONSProtocol Systems, Inc.K894973RESPITRACE PLUSHogan & HartsonK832999RESPIRATION MONITORLitton Medical ElectronicsK830778MONITORING KIT AMK-1Alternative Design Systems, 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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