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FDA 510(k)

LIFECARE PRESSURE ALARM CAT. NO. 34-010

K-Number: K894361 · 1989-10-05

ApplicantLifecare Services, Inc.
Decision Date1989-10-05
Product CodeCAP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LIFECARE PRESSURE ALARM CAT. NO. 34-010 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 1989-10-05 under 510(k) number K894361. The device is classified under product code CAP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFECARE PRESSURE ALARM CAT. NO. 34-010?

LIFECARE PRESSURE ALARM CAT. NO. 34-010 is a medical device that received FDA 510(k) clearance on 1989-10-05. The listed applicant is Lifecare Services, Inc.. The 510(k) number is K894361.

When did LIFECARE PRESSURE ALARM CAT. NO. 34-010 receive FDA 510(k) clearance?

LIFECARE PRESSURE ALARM CAT. NO. 34-010 received FDA 510(k) clearance on 1989-10-05, under 510(k) number K894361.

Who is the listed applicant for LIFECARE PRESSURE ALARM CAT. NO. 34-010?

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 PRESSURE ALARM CAT. NO. 34-010?

The FDA product code for LIFECARE PRESSURE ALARM CAT. NO. 34-010 is CAP.

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 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.

K913423LIFECARE REMOTE ALARM IIK912224LIFECARE CPAP-100K910947NEV-10 NEGATIVE PRESSURE VENTILATORK894779LIFECARE NASAL MASK KIT CAT. NO. 06-800K895592FREEWAY NEBULIZER COMPRESSORK880378LOTA, LIFECARE OXYGEN/TEMPERATURE ANALYZER 36-001

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Related Devices (Code: CAP)

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.

K201666SINGLE USE MANOMETERFlexicare Medical Limited.K182292VORTRAN APM-PlusVortran Medical Technology 1, Inc.K180510NS 120P-TRS Airway Pressure GaugeInstrumentation Industries, Inc.K172284NAPA LP-15 Airway Pressure MonitorDrw Medical, LLCK153733VORTRAN ManometerVortran Medical Technology 1, Inc.K122627GIO DIGITAL PRESSURE GUAGESGalemed Corp.

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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