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FDA 510(k)

LIFECARE REMOTE ALARM II

K-Number: K913423 · 1992-01-30

ApplicantLifecare Services, Inc.
Decision Date1992-01-30
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LIFECARE REMOTE ALARM II is the device name listed in this FDA 510(k) record. The listed applicant is Lifecare Services, Inc.. It received FDA 510(k) clearance on 1992-01-30 under 510(k) number K913423. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFECARE REMOTE ALARM II?

LIFECARE REMOTE ALARM II is a medical device that received FDA 510(k) clearance on 1992-01-30. The listed applicant is Lifecare Services, Inc.. The 510(k) number is K913423.

When did LIFECARE REMOTE ALARM II receive FDA 510(k) clearance?

LIFECARE REMOTE ALARM II received FDA 510(k) clearance on 1992-01-30, under 510(k) number K913423.

Who is the listed applicant for LIFECARE REMOTE ALARM II?

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

What is the FDA product code for LIFECARE REMOTE ALARM II?

The FDA product code for LIFECARE REMOTE ALARM II is CBK.

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Other records listing Lifecare Services, 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.

K912224LIFECARE CPAP-100K910947NEV-10 NEGATIVE PRESSURE VENTILATORK894779LIFECARE NASAL MASK KIT CAT. NO. 06-800K895592FREEWAY NEBULIZER COMPRESSORK894361LIFECARE PRESSURE ALARM CAT. NO. 34-010K880378LOTA, LIFECARE OXYGEN/TEMPERATURE ANALYZER 36-001

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Related Devices (Code: CBK)

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.

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO KgaaK252663Inbentus VersatileIconic Solutions by Murcia, SLK251888VPAP Pediatric Face MaskHsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented FullFisher & Paykel Healthcare, Ltd.K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics 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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