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FDA 510(k)

PERSONAL ALERT ASSIST DEVICE

K-Number: K890445 · 1989-05-19

ApplicantSilent Call Corp.
Decision Date1989-05-19
Product CodeLXI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PERSONAL ALERT ASSIST DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Silent Call Corp.. It received FDA 510(k) clearance on 1989-05-19 under 510(k) number K890445. The device is classified under product code LXI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERSONAL ALERT ASSIST DEVICE?

PERSONAL ALERT ASSIST DEVICE is a medical device that received FDA 510(k) clearance on 1989-05-19. The listed applicant is Silent Call Corp.. The 510(k) number is K890445.

When did PERSONAL ALERT ASSIST DEVICE receive FDA 510(k) clearance?

PERSONAL ALERT ASSIST DEVICE received FDA 510(k) clearance on 1989-05-19, under 510(k) number K890445.

Who is the listed applicant for PERSONAL ALERT ASSIST DEVICE?

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

What is the FDA product code for PERSONAL ALERT ASSIST DEVICE?

The FDA product code for PERSONAL ALERT ASSIST DEVICE is LXI.

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 Silent Call 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.

K890596MED-A-CALL ASSIST DEVICE

Related Devices (Code: LXI)

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.

K930573SYNVASIVE CERAMIC SUTTING BLOCKSynvasive Technology, Inc.K910712VILLAN (VIDEO LIFT LINK ANALYSIS)Physio Systems, Inc.K892655ACL DRILL GUIDE SYSTEMBaxter Healthcare CorpK882407BOW & ARROW DRILL GUIDEInstrument Makar, Inc.K881378PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDEPfizer, Inc.K880739DYONICS DRILL GUIDE/ISOMETER SYSTEMDyonics, 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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