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FDA 510(k)

HANNAH WIRELESS VITAL SIGNS MONITOR

K-Number: K991087 · 2000-01-12

ApplicantIlife Systems, Inc.
Decision Date2000-01-12
Product CodeFLS
Advisory CommitteeAN
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

HANNAH WIRELESS VITAL SIGNS MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Ilife Systems, Inc.. It received FDA 510(k) clearance on 2000-01-12 under 510(k) number K991087. 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 HANNAH WIRELESS VITAL SIGNS MONITOR?

HANNAH WIRELESS VITAL SIGNS MONITOR is a medical device that received FDA 510(k) clearance on 2000-01-12. The listed applicant is Ilife Systems, Inc.. The 510(k) number is K991087.

When did HANNAH WIRELESS VITAL SIGNS MONITOR receive FDA 510(k) clearance?

HANNAH WIRELESS VITAL SIGNS MONITOR received FDA 510(k) clearance on 2000-01-12, under 510(k) number K991087.

Who is the listed applicant for HANNAH WIRELESS VITAL SIGNS MONITOR?

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

What is the FDA product code for HANNAH WIRELESS VITAL SIGNS MONITOR?

The FDA product code for HANNAH WIRELESS VITAL SIGNS MONITOR is FLS.

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.

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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.K962865REMBRANDT SYSTEMAirsep Corp.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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