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FDA 510(k)

MODEL DX MICRO COMPUTER CONTROL

K-Number: K970094 · 1997-05-12

ApplicantInvacare Respiratory Corp.
Decision Date1997-05-12
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MODEL DX MICRO COMPUTER CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Invacare Respiratory Corp.. It received FDA 510(k) clearance on 1997-05-12 under 510(k) number K970094. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL DX MICRO COMPUTER CONTROL?

MODEL DX MICRO COMPUTER CONTROL is a medical device that received FDA 510(k) clearance on 1997-05-12. The listed applicant is Invacare Respiratory Corp.. The 510(k) number is K970094.

When did MODEL DX MICRO COMPUTER CONTROL receive FDA 510(k) clearance?

MODEL DX MICRO COMPUTER CONTROL received FDA 510(k) clearance on 1997-05-12, under 510(k) number K970094.

Who is the listed applicant for MODEL DX MICRO COMPUTER CONTROL?

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

What is the FDA product code for MODEL DX MICRO COMPUTER CONTROL?

The FDA product code for MODEL DX MICRO COMPUTER CONTROL is ITI.

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 Invacare Respiratory 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.

K962583CAT SCOOTER WITH DS60 VONYTOLLRT

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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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Official Source

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