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FDA 510(k)

CLINITRON ELEXIS

K-Number: K943385 · 1995-02-27

ApplicantSsi Medical Services, Inc.
Decision Date1995-02-27
Product CodeINX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CLINITRON ELEXIS is the device name listed in this FDA 510(k) record. The listed applicant is Ssi Medical Services, Inc.. It received FDA 510(k) clearance on 1995-02-27 under 510(k) number K943385. The device is classified under product code INX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLINITRON ELEXIS?

CLINITRON ELEXIS is a medical device that received FDA 510(k) clearance on 1995-02-27. The listed applicant is Ssi Medical Services, Inc.. The 510(k) number is K943385.

When did CLINITRON ELEXIS receive FDA 510(k) clearance?

CLINITRON ELEXIS received FDA 510(k) clearance on 1995-02-27, under 510(k) number K943385.

Who is the listed applicant for CLINITRON ELEXIS?

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

What is the FDA product code for CLINITRON ELEXIS?

The FDA product code for CLINITRON ELEXIS is INX.

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 Ssi Medical 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.

K942184CLINITRON AT HOME AIR FLUIDED THERAPYK914351CLINITRON C-10K890523SUPERCAIRK882161ACUCAIR CUSHION CONTINUOUS AIRFLOW SYSTEMK863047FLEXICAIR

Related Devices (Code: INX)

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.

K972176HOME CARE BEAD BEDKinetic Concepts, Inc.K964223CLINITRON RITE-HITEHill-Rom, Inc.K942184CLINITRON AT HOME AIR FLUIDED THERAPYSsi Medical Services, Inc.K931168X-20 AIR SUPPORT BEDAmerican Life Support Technology, Inc.K934689LOW AIR LOSS MATTRESS, MODIFICATIONCardio Systems, Inc.K924973DYLNAMEDICS A.S.A.P.Dynamedics, 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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